Freudenberg Medical (Carpinteria, Calif.) today touted extractables testing performed on its PharmaFocus Premium silicone tubing used in biopharma fluid processing and single-use applications. Eurofins Lancaster Laboratories conducted the independent extractables testing for Freudenberg Medical, drawing on BPOG and USP 665 protocols. “We understand that identifying extractable and leachable substances is extremely important for our biopharma […]
This coin-sized insulin patch could improve diabetes treatment
Could treating diabetes someday be as simple as slapping on a patch? A UCLA-led research team thinks so, and it’s seeking FDA permission to prove it. A research team led by UCLA bioengineering professor Zhen Gu claims to have overcome some of the technological hurdles around creating a patch that releases insulin based on the […]
Insulet’s Omnipod Dash Personal Diabetes Managers have a glitch
Insulet (NSDQ:PODD) is issuing a voluntary medical device correction for all of the smartphone-like Personal Diabetes Managers that came with its next-gen Omnipod Dash insulin management system, the company announced today. During its ongoing quality management process, Insulet officials discovered that the PDMs on rare occasions will suggest an inaccurate bolus amount based on a blood […]
FDA says Medtronic MiniMed insulin pump recall is serious
The U.S. FDA has designated a recall of hundreds of thousands of Medtronic Minimed insulin pumps as Class I — the most serious type of recall. Medtronic (NYSE:MDT) first warned of safety problems with the pumps in November. The recall involves 322,005 pumps — MiniMed 630G (model MMT-1715) and MiniMed 670G (model MMT-1780) — in the […]
Abbott boosts support for Bigfoot Biomedical and its diabetes treatment tech
Diabetes treatment tech company Bigfoot Biomedical has raised another $45 million in the initial tranche of a Series C equity financing, with collaborator Abbott (NYSE:ABT) as the lead investor. “We are excited to announce Abbott’s deepening support of Bigfoot Biomedical with this Series C financing,” Bigfoot Biomedical CEO Jeffrey Brewer said in a news release today. […]
Phillips-Medisize expands Denmark site
Phillips-Medisize, a Molex company, announced today that it has expanded its Global Innovation and Development site in Struer, Denmark. The Hudson, Wis.–based company — a contract manufacturing giant in the drug delivery device space — plans to open a dedicated Manufacturing Development and Clinical build unit in Stuer by the second quarter of 2020. Get […]
Medinol stent performs just as well as Medtronic Resolute, study says
The EluNIR drug-eluting stent made by Medinol performed just as well as the Resolute Integrity or Resolute Onyx stents from Medtronic (NYSE:MDT), according to new clinical study results from an international team of researchers. The randomized clinical trial — conducted by researchers from the U.S., Israel, Canada and the Netherlands — involved 2,221 people and compared […]
Delcath Systems announces reverse stock split
A reverse stock split went into effect today for Delcath Systems (OTC:DCTH) — developer of the Chemostat hepatic delivery system for treating cancer. The 1-for-700 reverse stock split is meant to reduce the number of common stock shares and shares reserved for issuance to 1.2 million, from a previous 1.4 billion. The authorized number of shares […]
W.L. Gore officials think they can spur insulin delivery system innovation
W.L. Gore announced this week that it is investing in PhysioLogic Devices, a startup developing an implantable intraperitoneal insulin delivery system. The size of the investment was not disclosed. But it was part of Gore’s Micro-Equity Investment (MEI) program, which provides investments of up to $500,000. W.L. Gore officials think the company’s more than 60 years […]
OncoSec $30m fundraise threatened by spat
OncoSec Medical (NSDQ:ONCS) is embroiled in a lawsuit and proxy war over a $30 million money-raise as it seeks to continue development of its cancer treatment technology. The company — headquartered in San Diego and Pennington, N.J. — sent a letter to shareholders today in which it countered what it described as false and misleading statements […]
