Taking certain steps — including some that are easily overlooked — can better protect your intellectual property. Thinking of designing your own medical device or launching a company? In recent DeviceTalks Weekly podcasts, two partners from the intellectual property law firm Finnegan, Henderson, Farabow, Garrett & Dunner, LLP shared several tips medical device company executives […]
BD’s Alaris pump hit with another serious recall
A medical supply company is recalling BD (NYSE:BDX) Alaris infusion pumps — the third Class I recall for the pumps in recent months, according to the FDA. North Carolina-based Avante Health Solutions issued the Alaris pump recall March 24, 2021, because the bezel repair posts may crack or separate, leading to the inaccurate delivery of […]
CMS extends joint replacement pricing by 3 years
The Centers for Medicare and Medicaid Services (CMS) has extended bundled pricing for hip and knee replacements for three years. The final rule, published in the Federal Register, extends the “Comprehensive Care for Joint Replacement” cost-bundling program through Dec. 21, 2024. The cost-cutting program began in January 2016, when CMS required all hospitals in 67 geographic […]
Stryker sees pandemic sales effects softening
Stryker (NYSE:SYK) executives see hip and knee procedures growing in 2021, based on a trend that started in March and continued in April. Such elective procedures were still sluggish in early 2021 due to the pandemic. Still, regional recovery from COVID-19 — particularly in the U.S. and Asia — bodes well for the company, CEO […]
Neurostimulation may help restore arm function years after stroke
Stroke survivors who received vagus nerve stimulation (VNS) combined with rehabilitation had better arm and hand function, according to the results of a new study. In the international, multi-center clinical trial, 53 participants with moderate to severe arm weakness nine months to 10 years post-stroke received rehabilitation paired with VNS. Fifty-five patients within the same […]
BD applies for FDA clearance to start shipping Alaris pumps again
BD (NYSE:BDX) said today that it has applied to the FDA for a new clearance for its recall-plagued Alaris infusion pump system. BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes needed following a Class I-level recall in March 2020. Pumps are only […]
Feds to healthcare: Limit reusing masks
The FDA recently told healthcare facilities they can start to limit the decontamination and reuse of disposable masks. An increase in the domestic supply of new masks approved by NIOSH has made the practice less necessary, the agency said. Get the full story on our sister site, Medical Design & Outsourcing.
Proximie raises $38M in Series B round
Digital surgery company Proximie this week announced it has raised $38 million in a Series B equity financing round. F-Prime Capital led the round, with participation from new investors Questa Capital, Eight Roads, Maverick Ventures. There was also support from existing investors Global Ventures, BECO Capital and Cedar Mundi Ventures. Proximie’s platform uses augmented reality (AR), machine […]
FDA loses ‘drug or device’ argument again
A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug. The decision counts as a win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body. Genus […]
Philips’ trade secret suit against Chinese companies can proceed
A federal judge has ruled that two companies in China and a U.S. company must face a trade secrets lawsuit by Philips. Philips claims that two former employees who joined GL Leading, an Aurora, Ill.-based firm allegedly formed from a pair of related companies in China, stole proprietary information about certain Philips’ X-ray tubes. Philips […]
FDA just made pooled COVID testing easier
COVID-19 molecular tests have already been authorized for individual use will have an easier time getting an FDA nod for pooled testing. The FDA said today it will add tests by manufacturers who validated their nasal specimen test for pooling to its list of tests available for use with pooled nasal specimens. This could expand […]