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 […]
U.S. investing $42m to boost BD syringe and needle production
HHS’s Biomedical Advanced Research and Development Authority is helping BD expand operations and manufacturing capacity in Nebraska to boost syringe and needle supplies for an eventual COVID-19 vaccine. Becton Dickinson (NYSE:BDX) said today that the total project will cost $70 million, with BARDA providing $42 million. The company expects the new capacity to be online within […]
CVRx raises $50m to support Barostim Neo commercialization
CVRx has raised $50 million in its latest round of equity financing — money the company will use to support the U.S. commercialization of its Barostim Neo heart failure treatment device. New investors Strategic Healthcare Investment Partners and Vensana Capital led the new funding round — with participation from other new investors, Hatteras Venture Partners […]
Medtronic Linq II insertable cardiac monitor gets OK in U.S., Europe
Medtronic (NYSE:MDT) announced today that its Linq II insertable cardiac monitor has received FDA clearance in the U.S., as well as a CE Mark in the EU. The Linq II boasts remote programming. That means a person with the Linq II implanted inside of them doesn’t need to return to the doctor’s office or hospital to […]
BD launches COVID-19 antigen test that can produce results in 15 minutes
Becton Dickinson (NYSE:BDX) announced today that it’s received an FDA emergency use authorization for its COVID-19 antigen test, which the company will start shipping this week. BD plans to ramp-up manufacturing capacity to 2 million tests per week by the end of September, with 10 million tests produced by the end of September. The tests run […]
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