The FDA issued revised guidance documents earlier this year clarifying the agency’s ‘Refuse to Accept’ policy for 510(k)s and PMAs. The updated policy raises questions for companies developing and submitting combination products for regulatory approval, according to lawyers Allyson Mullen and Rachael Hunt. The associate partners detailed changes to the components that companies must include […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Abiomed wins FDA nod for Impella CP with SmartAssist, taps Trapp as CFO
Abiomed (NSDQ:ABMD) said today it won FDA pre-market approval for its next-gen Impella CP heart pump with the SmartAssist optical sensor, and announced late last week that it named Todd Trapp its new CFO. The newly cleared Impella CP with SmartAssist features improvements intended to simplify patient management, integrate clinical data informatics including left ventricular pressure, […]
Intersect ENT launches Sinuva steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) launched its steroid-releasing sinus implant, Sinuva, in the U.S. today. The company’s drug-eluting device is designed to treat nasal polyp disease in patients who have undergone previous sinus surgery. Sinuva is placed during a routine doctor’s office visit and releases an anti-inflammatory steroid, mometasone furoate, directly to the patient’s nasal polyps for up to […]
Myriad’s breast cancer diagnostic wins approval in Japan
Myriad Genetics (NSDQ:MYGN) subsidiary Myriad Genetics Laboratories said today that the Japanese Ministry of Health, Labor & Welfare approved its Bracanalysis Diagnostic System to be used with Lynparza – a breast cancer drug marketed by AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK). Lynparza is a PARP inhibitor designed to target deficiencies in DNA damage response pathways. AstraZeneca and Merck are working to […]
Dexcom CEO on ‘treading new ground’ with G6 glucose monitor
Kevin Sayer sold his first glucose sensor in 1994. More than twenty years later, the chief executive of Dexcom (NSDQ:DXCM) still believes that glucose-monitoring technology can transform the way patients manage their diabetes. This week, Dexcom won FDA approval for its latest continuous glucose monitor. The G6 system is the first of the company’s that does […]
FDA reschedules eMDR system update
The FDA recently announced that the eMDR adverse event code update that was originally set to take place on April 6 has been rescheduled for July 5. The delay in update will give AS2 submitters more time to develop and validate changes to adverse event compliant handling system with the test eMDR system that was […]
Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease
Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease. The Marlborough, Mass.-based company is testing the film as a therapy for Parkinson’s patients experiencing “off” episodes – when symptoms that are otherwise controlled by medications resurface. As […]
Foundation Medicine launches genomic profiling test for solid tumors
Foundation Medicine (NSDQ:FMI) today launched the first FDA-approved comprehensive genomic profiling assay for all solid tumors in the U.S. The test, FoundationOne CDx, is designed to detect specific genomic alterations and help doctors make personalized treatment decisions for their patients. Get the full story at our sister site, Drug Delivery Business News.
FDA committee backs Senseonics’ implantable continuous glucose monitor
An FDA advisory panel voted unanimously to recommend approval for Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor, Eversense, the company touted this week. The panel of medical experts voted 8-0 that the benefits of the technology outweigh the risks and that the system, which works for up to 90 days, is safe and effective. Get the full […]
LivaNova wins expanded CE Mark labeling for Bicarbon aortic valve
LivaNova (NSDQ:LIVN) said today it won expanded CE Mark labeling for its Bicarbon aortic heart valves, now cleared for use with low-dose anticoagulant therapy. The new approval clears low risk patients who’ve received a Bicarbon aortic valve implant to be targeted using a lower international normalized ratio measurement of blood coagulability, allowing for a lower-range level […]
pSivida buys Icon Bioscience and rebrands as EyePoint Pharmaceuticals
With the help of $61 million from EW Healthcare Partners and a third-party investor, pSivida (NSDQ:PSDV) announced today that it acquired Icon Bioscience and its FDA-approved dexamethasone intraocular suspension designed to treat postoperative inflammation. The two companies combined and plan to do business as EyePoint Pharmaceuticals. pSivida also landed a $20 million debt facility from SWK Holdings Corp., to […]