Bayer (ETR:BAYN) failed to tell FDA about thousands of injury complaints related to its Essure contraceptive device, according to newly unsealed lawsuit documents reported by Bloomberg. The lawsuit documents out of California claim that the underreporting went back before Bayer acquired Essure maker Conceptus for $1.1 billion in 2013. Bayer responded to Bloomberg last week that […]
Federal Trade Commission sues online retailer over its PPE shipment speed claims
The Federal Trade Commission has sued online retailer SuperGoodDeals.com — claiming that it falsely promised consumers next-day shipping of facemasks and other personal protective equipment amid the COVID-19 pandemic. SuperGoodDeals’ website starting in March said PPE was “in stock,” and touted “Pay Today, Ships Tomorrow” — but it often took weeks for PPE merchandise to […]
Insightec wins Medicare coverage for incisionless neurosurgery platform
Insightec announced today that it has secured complete Medicare coverage across the U.S. for its MR-guided focused ultrasound treatment of medication-refractory essential tremor. The coverage comes roughly four years since the Tirat Carmel, Israel–based company won FDA approval for the technology. Insightec officials said compelling clinical evidence and support from physicians, specialty societies and patients […]
MedTech 100 roundup: Medtech stocks bump along
Medical device company stocks appear to be in a holding pattern as investors wait for new earnings reports. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — bumped along last week. It closed at 84.39, about where it had been at the start of the week. The Dow Jones […]
FDA plans to resume onsite inspections later this month
FDA has a goal of restarting on-site inspections during the week of July 20 — four months after it temporarily halted them — though there will be changes due to the COVID-19 pandemic. The agency today said that it will pre-announce inspections to FDA-regulated businesses. Said FDA: “This will help assure the safety of the […]
Biopharmaceutical companies pledge more than $1 billion to develop new antibiotics
More than 20 biopharmaceutical companies around the world have pledged more than $1 billion toward the Antimicrobial Resistance (AMR) Action Fund that launched today. Pledges include $100 million from Pfizer and $50 million from Boehringer Ingelheim. An initiative of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the fund’s goal is to bring two to four […]
3M resolves N95 fraud case in Indiana
3M (NYSE:MMM) announced today that it has resolved a federal court lawsuit in Indiana against an entity called ZeroAqua, halting a fraudulent N95 scheme involving the promise of billions of nonexistent N95 respirators. The lawsuit was among a handful that 3M filed nationwide more than two months ago — part of a larger legal effort in […]
Medtronic, Tandem Diabetes Care bury the hatchet on potential IP disputes
Two major insulin pump makers — Medtronic (NYSE:MDT) and Tandem Diabetes Care (NSDQ:TNDM) — announced today that they’ve inked a non-exclusive patent cross-license agreement related to diabetes treatment tech. The companies said the agreement will allow them to focus on innovation while avoiding the distraction of potential legal disagreements. The deal could be but another example of […]
Magstim acquires high-density EEG tech from Philips
Transcranial magnetic stimulation tech developer Magstim recently announced that it has purchased the product portfolio of Electrical Geodesics from Royal Philips (NYSE:PHG). Financial terms of the deal were not disclosed. Magstim will acquire EGI’s hardware, software and sensor nets assets and will immediately manage global sales, service and support, maintaining a presence in EGI’s Oregon office. […]
CHF Solutions announces new president, COO
CHF Solutions (NSDQ:CHFS) recently announced that it has promoted Nestor Jaramillo Jr. to the president and COO spot at the company. Jaramillo’s promotion was effective July 1. Jaramillo has been at the Eden Prairie, Minn.-based fluid overload treatment developer since May 2019, focusing on commercial growth. “Nestor has had a strong impact on our commercial success […]
FDA clears Nonin Medical flagship product
Nonin Medical (Plymouth, Minn.) announced today that it has received 510(k) clearance for its flagship product — the CO-Pilot wireless handheld multi-parameter system. The handheld, wireless CO-Pilot is meant to make it easier for EMS, firefighters and military personnel to measure a person’s key vital signs following a cardiac arrest, traumatic injury, carbon monoxide or […]