Stereotaxis to Buy Robocath for up to $45M
Stereotaxis announced it will acquire French robotic‑surgery firm Robocath for up to $45 million, paying $20 million upfront and up to $25 million contingent on milestones such as FDA clearance of Robocath’s next‑generation system. The deal merges Stereotaxis’s magnetic navigation platform with Robocath’s mechanical bedside robot, expanding capabilities across electrophysiology, interventional cardiology and neuro‑interventions. Robocath’s R‑One+ system, already installed in 15 sites in Europe, will become a Stereotaxis subsidiary and is projected to generate $2 million in revenue its first year, reaching break‑even by year three.
CBP Preps Tariff Refund Portal for April 20 Launch
U.S. Customs and Border Protection will activate its dedicated IEEPA tariff refund portal, CAPE, on April 20 at 8 a.m. EDT. The system will allow importers to submit refund requests electronically, with 82% already signed up for e‑payments. CBP estimates about $127 billion...
J&J’s Cardiovascular Unit Stands Out Again in Q1
Johnson & Johnson’s medtech division is accelerating a strategic shift toward high‑growth cardiovascular and surgical‑robotics markets, backed by roughly $30 billion in recent acquisitions. In Q1 2026 the cardiovascular unit posted 13% growth, generating $2.38 billion, while Abiomed and Shockwave revenues rose...
Stryker to Buy Amplitude Vascular Systems
Stryker announced an agreement to acquire Amplitude Vascular Systems, a Boston‑based developer of intravascular lithotripsy (IVL) technology. The Pulse IVL system, which uses carbon‑dioxide‑driven pressure waves to fracture calcified plaque, remains investigational but is expected to clear key markets, strengthening...
The Seal Strength Paradox: Why More Is Not Always Better in Sterile Barrier Packaging
The article explains why increasing heat, pressure, or dwell time in sterile barrier packaging can backfire, leading to over‑sealing that weakens overall seal reliability. A real‑world case showed that boosting sealing temperature to fix intermittent tears actually introduced new failure...
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...
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...
