Regeneron Pharmaceuticals (NSDQ:REGN) announced today that its COVID-19 antibody drug reduced hospitalization and death risk by 70% in clinical trials. The definitive Phase 3 outcomes trial in high-risk, non-hospitalized COVID-19 patients met its primary endpoint in displaying that the REGEN-COV (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg […]
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Federal judge won’t let Boston Scientific avoid Watchman lawsuit
A federal judge in western North Carolina has declined to dismiss a wrongful death lawsuit against Boston Scientific (NYSE:BSX) over its Watchman stroke prevention device. Boston Scientific had sought to have the suit — brought by the Jean Penland estate — dismissed based on the Supreme Court’s decade-old Riegel v. Medtronic decision. The Riegel ruling […]
Companies, docs alarmed by proposed 510(k) rollback
Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process. HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes home ventilators, […]
Boston Scientific settles host of state pelvic mesh lawsuits for nearly $189M
Boston Scientific (NYSE:BSX) has agreed to pay $188.6 million to 47 states and the District of Columbia to resolve claims that it deceptively marketed transvaginal surgical mesh devices, state AGs announced today. Pelvic mesh products have been one of the medical device industry’s worst failures so far in the 21st century. First cleared nearly two […]
Envoy Medical touts study results for its Esteem middle ear implant
Envoy Medical announced today that its Esteem middle ear implant showed statistically significant improvements in postoperative results. White Bear Lake, Minn.–based Envoy’s Esteem osseointegrated active middle ear implant (AMEI) is for patients with moderate-to-severe sensorineural hearing loss who have failed to benefit from traditional amplification like hearing aids. Esteem is the first and only fully […]
FDA second-in-command to leave agency
Dr. Amy Abernethy, a top FDA official who was reportedly considered for the commissioner’s job, plans to leave the agency by the end of April. As principal deputy commissioner, Abernethy helps oversee the FDA’s day-to-day functioning and directs initiatives that cut across its regulatory centers covering drugs, medical devices, tobacco and food. She is also […]
Fresenius to provide more home dialysis machines to DaVita
Fresenius Medical Care North America (FMCNA) has expanded its agreement with DaVita Kidney Care to provide NxStage home hemodialysis machines and related technology to DaVita’s U.S. patients. “We are excited to expand our longstanding collaboration with DaVita to help more patients benefit from the portability, dependability, and flexibility of our NxStage home machines, which are […]
Alphatec to run new distribution center out of Tennessee
Alphatec (Nasdaq: ATEC) announced today that it will lease a 75,000 ft2 facility in Memphis, Tenn. to house its primary distribution operations. The spine surgery tech company plans to open the new distribution facility in July and aggressively ramp up operations in the Home of the Blues in coming years. ATEC’s Carlsbad, Calif. headquarters will continue […]
LumiraDx warns on false-positives with SARS-CoV-2 antigen test
LumiraDx issued an urgent device recall regarding a software update for its SARS-CoV-2 antigen test. The company received a customer complaint regarding a suspected false-positive result with the antigen test on Dec. 29, 2020. An investigation into the complaint identified a manufacturing issue that resulted in a small number of sequential test strips in certain […]
Makower named new director of Stanford Byers Biodesign
The Stanford Byers Center for Biodesign last night announced a new director with a familiar face – its co-founder Josh Makower, one of the more successful and prolific medtech entrepreneurs. This represents a homecoming of sorts for Makower, who co-founded the Stanford University center with Paul Yock in 2000. For years he’s also led the […]
NIAID expresses concern over AstraZeneca’s COVID-19 vaccine data
The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial. NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned that information the company released from its AZD1222 vaccine clinical trial may be outdated. In turn, that […]