In part 2 of an interview, we follow up with last week’s guest, CVRx CEO Nadim Yared, to catch up on how the medtech executive is managing during the pandemic. Yared also shares some far-reaching views on what the medtech industry needs to work toward to improve diversity in its workforce and provide equality for […]
What kinds of COVID-19 tests are out there?
Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it. To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing […]
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. […]
Essure study shows more pain, bleeding in women with implant
Interim results from a postmarket study of the Bayer (ETR:BAYN) Essure permanent birth control device revealed higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control. The FDA posted the results as part of a long-term safety evaluation of the device, which has […]
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 […]
Boston researchers have created a potential N95 mask alternative
Brigham & Women’s Hospital says it is developing a new, sustainable alternative to N95 respirator masks that are in demand during the COVID-19 pandemic. A team of bioengineers and clinical experts at the Boston-based hospital and the Massachusetts Institute of Technology (MIT) are working on the “injection molded autoclavable, scalable, conformable” iMASC system for providing […]
Report: Medtronic makes a bid for Intersect ENT
Intersect ENT (NSDQ:XENT) shares soared today on news that Medtronic (NYSE:MDT) has made a bid for the Menlo Park, Calif.-based ear, nose and throat condition treatment developer. Bloomberg reported the transaction late Tuesday, attributing the news to “people with knowledge of the matter.” Traders sent Intersect ENT shares up 38% in premarket trading. Medtronic declined to comment. […]
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