The U.S. FDA today announced a memorandum of understanding with the Department of Defense to accelerate regulatory assessment of medical products for military personnel. Congress last year passed a law to expedite regulatory review of products to diagnose, treat or prevent serious diseases or conditions facing U.S. military personnel. The memorandum establishes a framework to implement […]
Report: MiMedx held lower-cost grafts from federal hospitals
MiMedx (NSDQ:MDXG), already embroiled in an internal accounting snafu and several federal probes, reportedly held from government hospitals some of the lower-cost products it made available to private hospitals. In limiting its regenerative wound care offering to U.S. Veteran Affairs Dept. and other federal caregivers, Marietta, Ga.-based MiMedx ran up the tab on taxpayers, the Wall […]
FDA grants DoD approval for freeze-dried plasma on the battlefield
The FDA said today it granted an emergency use authorization to the US Department of Defense for the use of particular freeze-dried plasma products designed for the treatment of hemorrhage or coagulopathy. The approval specifically covers the use of pathogen-reduced leukocyte-depleted freeze-dried plasma produced by the Centre de Transfusion Sanguine des Armées, known in the […]
FDA, Pentagon reveal plan to speed medical devices, drugs to military personnel
The FDA and the Pentagon said today that they’re launching a joint program to speed the development of medical products for military personnel. The federal safety watchdog and the Defense Dept.’s Office of Health Affairs said the program’s framework is based on a House bill passed last year that expands the FDA’s authority to approve the […]
Carefusion wins $50m Pentagon contract
Becton Dickinson & Co. (NYSE:BDX) subsidiary CareFusion won a U.S. Defense Dept. contract worth nearly $50 million, the Pentagon said yesterday. San Diego-based Carefusion Solutions won the five-year, $49.5 million contract for medical equipment. The firm-fixed-price with economic-price-adjustment deal was awarded after the military reviewed bids from 31 suitors and is good to Dec. 20, 2022. The Pentagon […]
Pentagon re-ups $14m General Electric contract for patient monitoring systems
The U.S. Defense Dept. yesterday said it’s picking up the ninth renewal of a contract with the patient monitoring business at GE Healthcare (NYSE:GE) that’s worth more than $14 million. Wauwatosa, Wis.-based GE Medical Systems Information Technology won the one-year renewal for the $14.4 million deal to provide patient monitoring systems, subsystems, accessories, consumables and training to […]
House approves FDA fast track for battlefield treatments
The U.S. House of Representatives yesterday approved a measure that would create a fast track at the FDA for medical devices and drugs intended for treating battlefield injuries, a day after passing a nearly $700 billion defense policy bill that would have allowed Defense Dept. to approve the treatments without the FDA’s participation. That provision […]
House passes DoD bill with room to renegotiate drug, device approval provision
The US House of Representatives this week passed a nearly $700 billion defense policy bill, but left room for negotiating new terms related to a controversial provision which would have given the Dept. of Defense the power to approve medical devices and drugs without FDA clearance. The house voted 356 to 70 to approve the […]
Report: Proposed DoD health committee could undermine the FDA
A new defense policy bill would give the US Department of Defense the power to approve drugs and medical devices without FDA clearance, according to a report from Politico. The bill has alarmed congressional health staff and the Dept. of Health and Human Services who claim it could erode medical safety, putting US soldiers at […]
Cardinal Health, Hamilton Medical, Zoll Medical score DoD contracts
Cardinal Health (NYSE: CAH) will receive $29.2 million under a new U.S. Department of Defense contract, with Hamilton Medical and Zoll Medical also securing contracts in the tens of millions of dollars. Cardinal Health’s contract win, announced Sept. 29, comes nearly eight months after Dublin, Ohio–based Cardinal Health secured a $2.25 billion surgical supplies contract […]
Defense Dept. awards DePuy $33m deal for surgical products
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes secured a $32,994,565 contract from the U.S. Department of Defense for medical surgical products last week. The nine-month contract comes with eight one-year and one 15-month option periods. The customers include the Army, the Navy, the Air Force, the Marine Corps and federal civilian agencies. Earlier this month, DePuy launched […]
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