IceCure Medical said today that it has signed Terumo (OTC:TRUMY;TYO:4543) as the exclusive distributor of its tumor-freezing technology in Japan and Singapore. Terumo will pay IceCure $2 million for the distro rights if IceCure obtains the appropriate regulatory approvals for its ProSense cryoablation device, designed to treat malignant breast tumors without surgery. This will include […]
Cook Medical relaunches Beacon Tip catheters in Europe
Cook Medical said today that has relaunched its Beacon Tip catheters in Europe, three years after withdrawing them from the market worldwide. The catheters are now available in the UK, Ireland, Norway, Sweden, Finland, Denmark, Germany, Poland, the Netherlands, Luxembourg, Belgium, France, Switzerland, Austria, Hungary, Spain and Italy. Cook said it is working on relaunching […]
FDA requires more postmarket data to keep certain devices on the market
The FDA would require medtech companies seeking certain premarket approvals to submit timely postmarket study data or risk losing those approvals. The requirement is part of a final guidance the agency released last week, detailing how it will consider uncertainty in making benefit-risk determinations on breakthrough device PMAs, de novo classifications and humanitarian device exemptions (HDEs). Get […]
Cerus Endovascular tops $5m funding goal, raises target to $20m
Cerus Endovascular raised its fundraising goal to $20 million this week after it pushed past its previous $5 million target by about $900,000, according to a regulatory filing. The Oxford, U.K.-based company is developing the Contour neurovascular system, which is designed to reduce the risk of rupture when treating patients with intracranial aneurysms. The Contour […]
Nevro launches clinical trial of diabetic neuropathy treatment
Nevro (NYSE:NVRO) said today that it has completed patient enrollment in a clinical trial of its Senza HF10 therapy for patients with painful diabetic neuropathy. The Redwood City, Calif.-based company said the prospective, multicenter, randomized controlled trial compares its HF10 therapy plus conventional medical management to conventional treatment alone in 216 patients at 18 centers in […]
Mallinckrodt shares fall following loss in patent dispute
Shares in Mallinckrodt Hospital Products (NYSE: MNK) have fallen 19% since a federal appeals court ruled on Tuesday that industrial gas company Praxair did not infringe its patents for a nitric oxide (iNO) delivery system. Nitric oxide gas has long been used to treat infants experiencing hypoxic respiratory failure and Mallinckrodt is the exclusive U.S. supplier […]
Alphatec CEO wins lawsuit against former employer NuVasive
Alphatec (NSDQ:ATEC) chairman & CEO Patrick Miles won summary judgment in a lawsuit filed by his former employer, NuVasive (NSDQ:NUVA), over his employment contract. Miles was chief operating officer of NuVasive when he left that company in October 2017 to take the reins at Alphatec. NuVasive sued Miles a week later, claiming that he enacted […]
J&J’s Ethicon loses pelvic mesh appeal in Pennsylvania
The Pennsylvania Supreme Court has upheld a $2.43 million verdict against Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon in a pelvic mesh injury case. Sharon Beltz and her husband, Walter Beltz Jr. of Pen Argyl, Penn., won the verdict in 2017 based on their complaint that Sharon Beltz had suffered injuries due to mesh erosion and […]
FDA clears Biobeat’s cuffless BP wearable
Patient-monitoring startup Biobeat said today that the FDA has cleared its patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. The Tel Aviv, Israel-based company’s technology is based on reflective photoplethysmography (PPG). Its devices use several LED sources, wavelengths and proprietary algorithms to receive […]
CDRH sets science priorities
The FDA’s Center for Devices and Radiological Health (CDRH) released its latest top 10 regulatory science priorities yesterday. They are: Use Big Data to aid in regulatory decision-making. Modernize biocompatibility and biological risk evaluation of device materials. Use real-world evidence and evidence synthesis across multiple domains in regulatory decision-making. Advance tests and methods for predicting […]
BD to spend $8m to cut EO emissions in Georgia
Becton Dickinson (NYSE:BDX) said this week it will spend $8 million to upgrade emissions controls at two medical device sterilization plants it operates in Georgia. The plants in Covington and Madison, Ga., both southeast of Atlanta, use ethylene oxide (EO) to sterilize medical devices. The federal Environmental Protection Agency recognizes EO as a carcinogen and lowered […]