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U.S. Attorney Michael Sullivan is making his last week on the job a busy one.
Just five days before he leaves public service for the oak-trimmed corridors of private practice, Sullivan announced a third guilty plea in the federal investigation of off-label promotion by former sales reps for Stryker Biotech.
The Food and Drug Administration issued a Class 1 recall for one of Teleflex Medical‘s balloon pump catheters, due to a problem with the device’s electronic volume setting.
The federal watchdog agency said it received 25 complaints, but no reports of injuries, about a problem it described as a faulty volume connection for the Everett-based company’s 30cc, 40cc and 50cc Intra Aortic Balloon Pump catheters made by its Arrow International subsidiary.
American Well landed its second contract with Blue Cross, Blue Shield, this time to provide its Online Care service to the healthcare provider’s Minnesota operation.
The Boston-based online healthcare services provider‘s first deal, inked last year, was with the healthcare provider’s Hawaii operation.
Online Care is a multimedia web interface that allows patients to virtually consult with physicians over the Internet.
SeraCare Life Sciences Inc. added healthcare veteran and private equity investor Harold Blue to its managing board.
Blue, a principal at HealthEdge Investment Partners of Tampa, Fla., will join the board of the Milford-based diagnostic services company even as it endures a year-long stock freefall.
On April 3, the Centers for Medicare & Medicaid Services published a decision memorandum announcing significant easing of its coverage requirements for Positron Emission Tomography (PET) testing of solid tumors and myeloma. A minimally invasive diagnostic imaging procedure, PET uses a radioactive tracers to evaluate glucose metabolism in tumors and in normal tissue.
The National Institutes of Health plans to issue $200 million in grants from the American Recovery and Reinvestment Act.
The new grants will serve large-scale research projects with the potential to drive investment and job creation in biomedical research and development, public health and health care delivery.
Scientists and doctors at the Food & Drug Administration wrote a letter April 2 to President Barack Obama to ask that he hold former and current senior officials at the federal watchdog agency accountable for their wrongdoing.
The letter details numerous instances in which FDA officials violated agency rules and, in some cases, federal law. It goes on to say that “sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too long.”
Local medical device firms fared well in Medical Device & Diagnostic Industry magazine’s annual award ceremony.
The awards, now in their 12th year, are sponsored by the magazine and its publisher, Canon Communications, to recognize “achievements of medical device manufacturers, their suppliers, and the many people behind the scenes.” The actual awards will be handed out at Canon’s Medical Design & Manufacturing (MD&M) East conference in June.
Local winners include:
A group of American medical device manufacturers joined to launch a Japanese trade council, the American Medical Devices and Diagnostics Manufacturers’ Assn.
The federal Food & Drug Administration shot down Stryker Corp.‘s application for expanded use of its bone-growth putty after a panel of outside experts voted 6-1 against allowing the expansion, the Reuters news service reported.
The watchdog agency’s panel found that bias may have influenced subjects in clinical trials for the medical device giant’s OP-1 putty, a genetically engineered protein used to stimulate bone growth in spinal surgeries.
Stryker’s biotech division is headquartered in Hopkinton.
Millstone Medical Outsourcing is expanding again, this time at its Memphis operation.
The Fall River-based inspection and clean room services provider is adding 12,000 square feet to its facility in the Bluff City, taking its total to 43,600 square feet and increasing its inspection, storage and distribution capacities.
It’s the second expansion this year for Millstone, which opened a second location in its Fall River home base in February.
