Delcath Systems (OTC:DCTH) has closed on a $9.5 million private placement round, bringing the total amount raised since July to $29.5 million. The Queensbury, N.Y.-based company priced the round at $1,000 per unit, with each unit consisting of a preferred convertible share worth 16,667 common shares, at a 6¢ strike price, and a five-year warrant […]
FDA grants breakthrough nod to Concept Medical for below-the-knee use of MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for below-the-knee (BTK) use of its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of peripheral artery disease. The Tampa, Fla.-based company won the same designation for MagicTouch for the treatment of coronary in-stent restenosis in April. The XTOSI clinical study at Sengkang […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]
Omnipod Dash sales drive Insulet Q2 results
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 […]
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 […]
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 […]
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