Insulet (NSDQ:PODD) reported second-quarter results yesterday that missed the consensus forecast on Wall Street, but raised its outlook for the rest of the year. The Acton, Mass.-based diabetes tech company reported profits of $1.4 million or $0.02 per share, on sales of $177.1 million for the three months ended June 30, 2019, for a bottom-line […]
B. Braun wins breakthrough nod for drug-coated balloon catheter
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR). The designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according to the […]
Bigfoot Biomedical inks deal with Pittsburgh health system
Bigfoot Biomedical today announced an agreement with Pittsburgh-based Allegheny Health Network (AHN) to further develop Bigfoot’s Unity investigational insulin delivery wireless platform. The diabetes startup described Unity as a first-in-kind, data-driven solution for optimizing insulin dosing and delivery. Bigfoot will work alongside AHN endocrinologists and primary care doctors to refine Unity’s clinical workflow features. “We understand […]
Mylan agrees to settle SEC EpiPen probe for $30 million
Mylan (NSDQ:MYL) is nearing a $30 million settlement with the Securities and Exchange Commission (SEC) over an investigation involving the company’s EpiPen auto-injector and the Medicaid drug rebate program. The SEC probe was announced in 2016, shortly after Mylan agreed to pay $465 million to the U.S. Department of Justice to settle claims that it […]
Acorda’s Parkinson’s device moves closer to E.U. approval
Acorda Therapeutics (NSDQ:ACOR) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are […]
Ocular Therapeutix’s ophthalmic device gains Medicare coverage early
Ocular Therapeutix (NSDQ:OCUL) said today that the Centers for Medicare and Medicaid Services has assigned a specific and permanent reimbursement J-code for its Dextenza ophthalmic insert, which is approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The code assigned to Dextenza through the Healthcare Common Procedure Coding System will become effective […]
FDA issues new postmarket guidance for drug-device products
The FDA has released final postmarket guidance for manufacturers of drug-device combination products. The guidance outlines how the agency expects manufacturers of combination products and those that make constituent parts of drug-device combinations to report adverse events and product malfunctions. Combination-product manufacturers will have five working days to report adverse events that require remedial action […]
BD updates infusion pump recalls
Becton Dickinson (NYSE:BDX) said today it has updated two voluntary recalls of certain Alaris infusion pump modules and infusion sets used with those modules. The FDA has designated both recalls as Class I, as the agency has received reports of several serious injuries associated with the recalled devices. The Alaris model 8100 modules were manufactured […]
Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
Taris Biomedical has announced the dosing of the first patient in a study of its TAR-200 system plus a programmed immune checkpoint inhibitor for the treatment of muscle-invasive bladder cancer (MIBC). The TAR-200 system continuously delivers the chemotherapy drug gemcitabine in the bladder for multiple weeks. The combination with Bristol-Myers Squibb’s Opdivo (nivolumab) will be […]
AxoSim touts results of nerve-on-a-chip study
A new study of AxoSim’s Nerve-on-a-Chip technology shows that the platform accurately provides key physiological readouts that could help speed the development of drugs to treat neurological disorders. The study also shows that Nerve-on-a-Chip technology is the first all-human in vitro model that can measure critical factors that were formerly only available using live animal models. […]