Some of the medical device industry’s most heralded disruptors wound up being its biggest failures. Here’s what we can learn from their mistakes. Fink Densford, Associate Editor No one in medtech sets out to fail. No one invests in building a device believing that, despite years of research and development, it won’t make the cut. […]
Food & Drug Administration (FDA)
Trump budget would double FDA user fees
The Trump administration’s proposed budget, released today, would double the user fees medical device companies pay to have the FDA review the safety and efficacy of their products. The budget proposal would set user fees at $2 billion for 2018, about $1 billion more than the fee schedule for this year (annualized to correspond to the calendar year). In […]
DJO Global wins FDA 510(k) for Exprt revision hip portfolio
DJO Global said today it won FDA 510(k) clearance for its Exprt revision hip portfolio. The newly cleared Exprt devices feature anatomically inspired designs with a focus on efficiency and strength, according to the San Diego, Calif.-based company. DJO Global also touted the system as 40-70% of the price of comparable systems. “Having a thoughtful approach […]
FDA panel rules that benefits of Endo’s Opana opioid no longer outweigh risks
An FDA advisory panel ruled yesterday that the benefits of Endo Pharmaceutical‘s opioid painkiller, Opana ER, no longer outweigh its risks. The painkiller has been linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana. The panel voted 18 to 8 that the drug’s benefits do not […]
Medtronic’s SynchroMed woes delay United Therapeutic’s Remodulin
Shares in United Therapeutics (NSDQ:UTHR) fell -3% yesterday on a possible delay for the release of a programmable infusion pump for its drug, Remodulin. Yesterday, the FDA updated Medtronic‘s (NYSE:MDT) Class I recall for the company’s SynchroMed II and SynchroMed EL implantable drug pumps. RBC Capital reportedly said the recall puts United Therapeutics at heightened risk for […]
Pulse Biosciences seeks FDA 510(k) for PulseTx system
Pulse Biosciences (NSDQ:PLSE) said today that it submitted a 510(k) application to the FDA for its PulseTx nano-pulse stimulation system. The Burlingame, Calif.-based company’s PulseTx system uses short-duration electrical pulses directed at solid tumors to induce immunogenic cell death. The cell death process exposes the tumor cell antigens to the immune system, which triggers an […]
FDA announces updates to Medtronic’s Class I recall for SynchroMed drug pumps
The FDA today updated Medtronic’s Class I recall for the company’s SynchroMed II and SynchroMed EL implantable drug pumps, which were designed to locally treat primary or metastatic cancer, chronic pain, and severe spasticity. The pumps were recalled in 2013 because they unintentionally delivered drugs during the priming bolus procedure and patients were at risk for […]
Trump’s pick for FDA chief faces questions over ties to drug industry
Although President Donald Trump’s nominee for FDA commissioner has won approval from lawmakers across the aisle, he is facing questions from consumer watchdog Public Citizen over his ties to the drug industry that will likely arise during his confirmation hearings. The Medical Device Manufacturer Association has voiced its approval for Scott Gottlieb, saying “Dr. Gottlieb is a […]
Teleflex wins FDA nod for Twin-Pass torque dual access cath
Teleflex (NYSE:TFX) said today it won FDA 510(k) clearance for its Twin-Pass torque dual access catheter designed for the placement and exchange of guidewires into the coronary or peripheral vasculature. The Wayne, Penn.-based company said it has launched the Twin-Pass dual access catheter both in the US and internationally. “The Twin-Pass torque catheter builds on Vascular Solutions’ […]
Medtronic wins extended FDA indication for bone cement
Medtronic (NYSE:MDT) said today that it won 510(k) clearance for its Kyphon Xpede bone cement for the fixation of pathological fractures of the sacral vertebral body using sacral vertebroplasty or sacroplasty. The regulatory win expands the product’s original indications beyond treating vertebral fractures due to osteoporosis, cancer or benign lesion. Nearly 54 million Americans suffer […]
Medtronic wins expanded FDA indication for Melody TPV
Medtronic (NYSE:MDT) said today it won extended FDA approval for its Melody transcatheter pulmonary valve, now indicated for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed. The Fridley, Minn.-based company touted the Melody TPV as the 1st transcatehter pulmonary valve to win such an indication from the federal watchdog. “Unlike other transcatheter […]