Pulse Biosciences Hires Liane Teplitsky as COO
Pulse Biosciences appointed former Abbott executive Liane Teplitsky as chief operating officer to accelerate its pulsed‑field ablation (PFA) strategy. The company is focusing R&D on the nPulse Cardiac Catheter, a percutaneous device for atrial fibrillation, after promising first‑in‑human data from 150 European patients. Teplitsky will oversee clinical, regulatory, quality and commercial functions, including a pivotal U.S. and European trial enrolling 215 drug‑resistant AF patients. The move follows a broader leadership reshuffle and a shift away from a surgical clamp program.
E2 Raises $80M to Market Thrombectomy Platform
Endovascular Engineering (E2) closed a $80 million Series C round to launch its Hēlo mechanical thrombectomy platform for pulmonary embolism. The funding, led by Norwest and Gilde Healthcare, will expand E2’s commercial team and sustain R&D after FDA clearance was secured last...
FDA, Medtech Industry Near MDUFA VI Agreement
The FDA and the medical‑technology industry have reached an agreement in principle on the next five‑year user‑fee framework, MDUFA VI, which will govern 2027‑2032. The deal commits the agency to hiring more than 500 additional device‑review staff to address chronic understaffing...
Judge Allows States’ Lawsuit over HHS Restructuring to Move Forward
A federal judge in Rhode Island denied the Department of Health and Human Services' motion to dismiss a lawsuit filed by 19 states and Washington, D.C. The states allege that HHS's 2025 restructuring and the layoff of roughly 10,000 employees...
CDRH Targets Hospital Readmissions with Home Device Innovation Challenge
The FDA’s Center for Devices and Radiological Health (CDRH) launched the Reducing Readmissions through Device Innovation for the Home Innovation Challenge to spur home‑based medical devices that can lower hospital readmissions. Nine devices will be chosen by Dec 4, 2026, and the...
One Year In: How Medtech Companies Are Coping with Tariff Challenges
One year after the Trump administration’s “Liberation Day” tariffs, medtech firms are still feeling the cost impact, with annual hits of $200 million to $500 million for large players. While the sector has not pursued large‑scale reshoring, companies are absorbing costs, seeking...
Philips Warns Not to Use Certain Nebulizers in Trilogy Evo Ventilator Recall
Philips has issued a field‑safety notice prohibiting the use of non‑pneumatic nebulizers, such as vibrating‑mesh models, with its Trilogy Evo line of ventilators. The FDA logged the action as a Class I recall, affecting more than 113,700 devices worldwide, including the Evo,...
Zimmer Hires Chief Science, Technology and Medical Affairs Officer
Zimmer Biomet announced the appointment of orthopedic surgeon Jonathan Vigdorchik as its chief science, technology and medical affairs officer, effective April 14. In his new role, Vigdorchik will oversee AI, robotics, smart implants, data analytics, and the company’s medical‑education strategy....
J&J Launches Enhanced PFA Device in Europe
Johnson & Johnson received CE‑mark approval for its Varipulse Pro pulsed‑field ablation (PFA) device and is launching it across Europe. The upgraded system delivers lesions five times faster than the prior sequence while maintaining comparable efficacy and operates at a lower...
UK Steps up Push to Align Medtech Regulations with the US
The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced a new collaboration with the US Food and Drug Administration to align medical‑device regulations. The partnership will explore mutual‑recognition mechanisms, allowing FDA‑cleared devices to fast‑track through UK reviews while preserving...
VDyne Secures FDA Nod to Start Pivotal Trial for Tricuspid Valve
VDyne received FDA approval for an investigational device exemption to launch its pivotal TRIVITA trial of a transcatheter tricuspid valve replacement system. The study will assess safety and efficacy in patients with severe symptomatic tricuspid regurgitation, a condition affecting roughly...
Hologic CEO Steve MacMillan to Retire After Go-Private Deal
Hologic announced that CEO Steve MacMillan will retire as the company completes a Blackstone‑TPG go‑private transaction valued at $18.3 billion. The deal, which received all regulatory approvals, will close Tuesday and delist Hologic from Nasdaq, paying shareholders $76 per share plus...
Boston Scientific Closes Buyout of Valencia Technologies
Boston Scientific has closed its acquisition of Valencia Technologies, securing the eCoin tibial nerve stimulator for the urge urinary incontinence market. The device, which received pre‑market approval in 2022, helped 68% of trial participants cut incontinence episodes by at least...
Scientists Urge EPA Not to Weaken Ethylene Oxide Emissions Standards
Scientists, clinicians, and community groups urged the EPA to keep its 2024 ethylene oxide (EtO) emissions standards for medical device sterilizers. The agency’s March proposal would lift restrictions, allowing an additional 7.8 tons of EtO per year and eliminating permanent enclosures...
Restore Robotics Cleared to Remanufacture 2 More Da Vinci Xi Instruments
Restore Robotics received FDA 510(k) clearance for two additional da Vinci Xi instruments—a permanent cautery hook and a permanent cautery spatula—bringing its total FDA‑cleared remanufactured instruments to four. The clearances follow earlier approvals for da Vinci scissors and expand the company’s portfolio of...
Merit Medical Acquires View Point for $140M
Merit Medical Systems announced a $140 million acquisition of View Point Medical, adding the FDA‑cleared OneMark Detection Imaging System and tissue markers to its oncology portfolio. The deal includes $90 million upfront and $50 million in two anniversary installments. Merit expects the OneMark...
‘Cracks Show’ as CDRH Staff Contend with Heavy Workloads
One year after the Trump administration’s sweeping HHS layoffs, the FDA’s Center for Devices and Radiological Health (CDRH) is grappling with severe understaffing and morale issues. Between September 2024 and January 2026 the agency shed roughly 21 % of its workforce—over 4,400 employees—leaving...
Distalmotion Targets ASC Robotic Gynecology Programs with FDA Filing
Distalmotion has filed a 510(k) request to add sacrocolpopexy, sacrocervicopexy and endometriosis resection to the FDA‑cleared indications for its Dexter robotic system. The move targets ambulatory surgical centers, where the robot’s small footprint could out‑compete larger platforms. The company recently...
Medtronic Wins CE Mark for OmniaSecure Defibrillation Lead
Medtronic has secured a CE mark for its OmniaSecure small‑diameter defibrillation lead, expanding the device’s European availability. The lead builds on the long‑standing SelectSecure Model 3830 pacing lead, offering a narrower profile without sacrificing durability. Clinical modeling predicts a 98.2% ten‑year...
Medtronic to Study Renal Denervation Combined with PCI
Medtronic announced the EMBRACE trial, a randomized study enrolling 1,000 patients to evaluate its Symplicity Spyral renal denervation system performed concurrently with percutaneous coronary intervention (PCI) in individuals with uncontrolled hypertension and multivessel disease. The company also released pooled data...
Medtronic Wins FDA Clearance for Robot in Cranial, ENT Surgeries
Medtronic has secured FDA 510(k) clearance for its Stealth AXiS surgical system, extending its use to cranial and ear‑nose‑throat (ENT) procedures. The modular platform combines AI‑enabled tractography, navigation and real‑time ultrasound, and can operate in both hospitals and ambulatory surgery centers....
Endologix to Close Production Facility, Lay Off 31 People
Endologix announced the closure of its Milpitas, California production facility, resulting in 31 layoffs. The plant was acquired in 2021 when Endologix bought PQ Bypass, adding the Detour peripheral arterial disease device to its portfolio. Layoffs will occur primarily on...
Abbott to Close $21B Exact Sciences Acquisition Monday
Abbott announced it will close its $21 billion acquisition of cancer‑test maker Exact Sciences on Monday after securing all regulatory approvals. The deal, the largest med‑tech transaction announced last year, brings Exact’s Cologuard colorectal screening and multi‑cancer blood tests under Abbott’s...
Intuitive Surgical Recalls Stapler Reloads over Issue Linked to Patient Death
Intuitive Surgical announced a voluntary recall of its 8 mm SureForm gray stapler reload cartridges after four serious injuries and one patient death were linked to incomplete staple lines. The FDA issued an early‑alert notice, prompting the company to ask customers...
MiniMed Gets FDA Nod for Smaller Insulin Pump
MiniMed, the diabetes‑tech spin‑out of Medtronic, received FDA clearance for its MiniMed Flex insulin pump, a device roughly half the size of the 780G model and operable via smartphone. The pump, featuring a 300‑unit reservoir, targets Type 1 patients aged 7+ and...
Vicarious Surgical Applies for Nasdaq Listing
Vicarious Surgical announced it has filed an application to list its Class A common stock on Nasdaq, following a NYSE delisting notice earlier this month. Under new CEO Stephen From, the company has implemented cost‑cutting measures and outsourced parts of...
Grail CEO Bob Ragusa to Retire
Grail announced that CEO Bob Ragusa will retire on June 1, 2026, and be succeeded by company president Josh Ofman. Ofman, who joined Grail in 2019 and served as chief medical officer before becoming president, steps into the role amid...
Intuitive Surgical Hit by Cybersecurity Phishing Incident
Intuitive Surgical disclosed a phishing breach that accessed employee and customer data via a compromised internal administrative network. The company promptly activated its incident‑response plan, secured affected applications, and confirmed that its da Vinci, Ion, and digital platforms remained untouched....
Insulet Reports 18 Serious Adverse Events with Recall of Omnipod 5 Insulin Pumps
Insulet announced a recall of select Omnipod 5 insulin patch pumps after discovering a small tear in the internal tubing that can cause insulin to leak inside the pod. The defect has been linked to 18 serious adverse events, including hospitalizations...
Genetic Tests Come Under Scrutiny in Trump Administration’s Fraud Crackdown
The Centers for Medicare & Medicaid Services (CMS) has issued a request for information (RFI) seeking public input on new regulatory tools to combat fraud in laboratory testing, especially genetic and molecular diagnostics. Genetic tests now represent 43% of Medicare...
FDA to Unify Agency’s ‘Fragmented’ Safety Surveillance System
The FDA launched the Adverse Event Monitoring System (AEMS), a unified dashboard that merges seven previously fragmented safety databases into a single platform. Four databases are already live, with the remaining three slated for integration by May, covering drugs, vaccines,...
Advita Ortho Receives Warning Letter Related to Shoulder System
Advita Ortho, a newly formed orthopedics company that acquired Exactech's assets, received an FDA warning letter in December concerning its Equinoxe Reverse Shoulder System. The letter highlighted undefined product specifications, inadequate supplier audits, incomplete production documentation, and persistent temperature and...
Medtronic Elevates Sean Haag to President of ENT
Medtronic has promoted Sean Haag from interim to permanent president of its ear, nose and throat (ENT) business. Haag, who joined Medtronic twenty years ago and most recently oversaw marketing and clinical for the AiBLE system, has been credited with...
Coloplast Names Former J&J Executive Gavin Wood as CEO
Coloplast announced that former Johnson & Johnson executive Gavin Wood will assume the role of chief executive officer on May 1, ending a ten‑month search for a permanent leader. Wood arrives after serving as J&J’s group chairman for MedTech across Europe,...
ARPA-H Launches Program to Develop Biosensors that Can Track Multiple Signals
The Advanced Research Projects Agency for Health (ARPA‑H) has launched the Delphi program to develop modular biosensors that can monitor multiple physiological signals such as inflammation markers, hormones, and drug levels. The initiative relies on electronic "chiplet" technology, allowing developers...
SS Innovations Raises $18.6M as Surgical Robot Nears US Market
SS Innovations announced an $18.6 million private placement to accelerate its global rollout, including a U.S. launch of the SSi Mantra surgical robot. The company filed for FDA 510(k) clearance in December, with a decision expected by mid‑2026, and aims to compete...
Zimmer Biomet Shares Smart Knee Data at AAOS
Zimmer Biomet presented claims‑based outcomes for its Persona IQ smart knee implant and MyMobility platform at the AAOS meeting. The analysis of 1,081 patients versus 4,324 controls showed a revision rate of 0.3% compared with 1% and a periprosthetic infection rate...
Cognito Raises $105M to Bring Alzheimer’s Treatment Device to Market
Cognito Therapeutics secured $105 million in Series C financing to advance its Spectris device, a non‑invasive light and sound system targeting Alzheimer’s disease. Early trials showed modest cognitive benefits despite no amyloid reduction, prompting a larger pivotal study with about...
Stryker Execs Discuss Mako RPS Launch at AAOS
Stryker unveiled its handheld surgical robot, Mako RPS, at the AAOS meeting, following FDA clearance and its first cases in January. The device is in a limited market release that will run through the first half of the year, with broader...
Inside CMR Surgical’s Big Pivot Before US Robot Launch
CMR Surgical’s new CEO, Massimiliano Colella, halted the planned U.S. debut of the first‑generation Versius robot, opting to wait for the upgraded Versius Plus platform. The second‑generation system secured FDA clearance for gallbladder‑removal surgery and is slated for a soft launch later...
Medtronic, GE HealthCare Expand Patient Monitoring Alliance
Medtronic and GE HealthCare have broadened a multi‑year partnership to embed Medtronic’s pulse oximetry, brain monitoring, capnography and regional oximetry technologies across GE’s bedside, telemetry and ambulatory monitoring platforms. The agreement accelerates integration of next‑generation Nellcor pulse oximetry and BIS...
Fresenius Kabi Recalls Ivenix Infusion Pumps over Software Problem
Fresenius Kabi issued a Class I recall for its Ivenix large‑volume infusion pumps after a software flaw was discovered that misreports battery capacity and can freeze the user interface. The FDA linked the defect to two serious injuries reported in November,...
Boston Scientific Gets Farapulse Label Expansion in Europe
Boston Scientific’s Farapulse pulsed field ablation system received a CE‑mark label expansion in Europe, now covering persistent atrial fibrillation lasting at least seven days. The decision follows positive safety and efficacy data from the ADVANTAGE AF trial. The move mirrors...
Intuitive Expands in Europe with Purchase of Distributor Operations
Intuitive Surgical completed a €319 million cash acquisition of the da Vinci and Ion distribution businesses operated by ab medica, Abex and Excelencia Robótica, gaining a direct commercial footprint in Italy, Spain, Portugal, Malta and San Marino. The deal brings roughly 250 former distributor...
Medtech M&A Starts Off Strong in 2026
Medtech M&A kicks off 2026 with several multibillion‑dollar deals. Boston Scientific announced a $14.5 billion acquisition of Penumbra, while Danaher disclosed a $9.9 billion purchase of Masimo. At the same time, major divestitures are underway, including BD’s planned $17.5 billion sale of its...
FDA Warns Beta Bionics on Unreported Complaints, Insulin Pump Changes
Beta Bionics received an FDA warning letter citing failure to report serious adverse events, unreported software and cybersecurity changes, and hardware defects in its iLet Bionic Pancreas system. The agency highlighted delayed reporting of hypoglycemia and hyperglycemia incidents, a five‑minute...
Labcorp Expands PathAI Pact to Roll Out Digital Pathology Platform in US
Labcorp announced an expanded partnership with PathAI to deploy the AISight Dx digital pathology platform across its U.S. anatomic pathology labs and hospital sites. The AI‑enabled software will allow pathologists to scan, annotate and diagnose slides digitally, aiming to cut turnaround...
Guardant Buys MetaSight for $59M Upfront to Acquire Blood Test Tech
Guardant Health has agreed to acquire Israel‑based MetaSight Diagnostics for $59 million in cash, with up to $90 million in performance‑based earn‑outs. MetaSight brings mass‑spectrometry‑driven multi‑omics liquid‑biopsy technology, targeting colorectal cancer, liver fibrosis, myocardial infarction, and diabetic kidney disease. The deal broadens...
Transforming Epilepsy Care: How Innovative Implantable Neurotechnology Offers New Hope
PRECISIS GmbH’s EASEE® epicranial neurostimulation system offers a minimally invasive alternative for drug‑resistant focal epilepsy. The implant, positioned under the scalp atop the skull, delivers targeted electrical pulses without opening the skull, achieving a median 68% seizure reduction over two...
Senseonics Launches Automated Insulin Dosing System with 1-Year CGM
Senseonics and Sequel Med Tech have launched an automated insulin‑delivery system that pairs the year‑long Eversense 365 implantable CGM with Sequel’s twiist pump. The integration, delayed to Q4 2025, marks the first AID solution using a one‑year sensor, contrasting with competitors’ 15‑day...