Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine. Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster shots against variants. In […]
George Soros and Bill Gates are helping to turn Mologic into a social enterprise
Mologic recently announced that it will transition into a social enterprise through the support of a group of philanthropic funds and investors led by the Soros Economic Development Fund, with support from the Bill & Melinda Gates Foundation. The investors that are part of the newly launched Global Access Health (GAH) are spending £30 million […]
Philips CPAP recall is Class I
FDA today designated a Philips recall of certain sleep and respiratory devices as Class I, its most serious level. Devices in the recall number in the millions, according to FDA’s database. There have been more than 1,200 complaints and more than 100 injuries involving polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. The foam has […]
Cardinal Health subsidiary faces federal lawsuit over EtO plant in Georgia
Nearly two dozen people who have lived in the Augusta, Ga. area are suing Cardinal Health subsidiary Kendall Patient Recovery U.S. over ethylene oxide emissions from a medical device sterilization plant in the city. The people suing KPR U.S. in U.S. District Court in Southern Georgia lived and worked within miles of the Augusta facility […]
NeuroMetrix stock skyrockets on news of FDA breakthrough device designation
NeuroMetrix (NSDQ:NURO) today announced that its Quell device has received FDA breakthrough designation for treating fibromyalgia symptoms in adults. The news saw NURO shares nearly triple in value to $9.72 apiece near the close of trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up 1.5%. Fibromyalgia involves the […]
RTI Surgical, Exactech form partnership to develop biologic bone substitutes
RTI Surgical announced a long-term agreement with Exactech for the development and supply of biologic bone substitutes. The deal, announced today, includes RTI Surgical acquiring Exactech’s FDA-cleared Optecure demineralized bone matrix, used as a bone graft extender in the spine, pelvis, and extremities. RTI Surgical officials think Optecure will complement their portfolio of bone graft […]
Nephros acquires GenArraytion pathogen detection tech
Nephros (Nasdaq: NEPH) announced today that it has acquired almost all of the assets of Rockville, Md.–based GenArraytion. The financial terms of the deal were not disclosed. Nephros officials said the purchase will give their company access to a host of GenArraytion proprietary assays, multiplexing technology, and selection methods for detecting waterborne pathogens and other […]
Abbott to pay $66M to settle suits involving St. Jude Medical and Alere
Abbott (NYSE:ABT) has reached settlements with the U.S. Department of Justice over False Claims Act lawsuits involving St. Jude Medical and Alere — two companies it spent billions of dollars to acquire in 2017. The Abbott Park, Ill.-based medtech giant will pay nearly $66 million as part of the settlements. Without admitting liability in either […]
Abbott to sell its STARLIMS informatics product suite
Global investment firm Francisco Partners announced today that it has agreed to acquire Abbott’s STARLIMS informatics product suite for an undisclosed amount. Companies in the life sciences, pharma and biotech, chemical and refining, food and beverage, manufacturing, environmental, public health and forensics sectors have used the STARLIMS suite of products for more than 35 years. […]
Could people one day get pacemakers that dissolve into the body?
Wireless, battery-free, fully implantable pacemakers made of bioresorbable components could represent the future of temporary pacing technology. Flexible, dissolvable electronics could soon pave the way for temporary pacemaker wearers to avert the risks associated with surgical procedures from initial implantation to the removal of the device once its job is done. Northwestern and George Washington […]
Neuroelectrics wins FDA breakthrough device designation for its epilepsy-treating neuromod
Brain stimulation tech developer Neuroelectrics announced today that it’s secured FDA breakthrough device designation for its Starstim neuromodulation platform to treat refractory focal epilepsy. Starstim includes transcranial electrical stimulation (tES), personalized treatment protocols and a secure cloud-based mechanism to deliver treatment anywhere. “We are excited to receive the FDA Breakthrough Device Designation for our lead […]
