Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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Section 3038 of the 21st Century Cures Act applies Hatch-Waxman rules to certain drug-device combination products, addressing the regulatory pathway for devices that incorporate already approved drugs.
The Hatch-Waxman Act, named for Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), was approved in 1984. It was designed to make it easier for generic drugs to enter the market by requiring manufacturers to submit an abbreviated new drug application and prove their drug’s bioequivalence to the original branded drug. This meant generic drug makers would not have to endure the laborious and costly process of clinical studies. Read more
Researchers from the Weizmann Institute of Science and Steba Biotech have reportedly developed a light-sensitive drug derived from deep-sea bacteria that has been shown to kill cancer cells in low-risk prostate cancer patients without affecting healthy tissue. The team’s work was published in Lancet Oncology.
Vascular-targeted photodynamic therapy, VTP, utilizes a drug called WST11 which was derived from bacteria that survive with very little sunlight at the bottom of the ocean. The bacteria have evolved to efficiently convert light into energy. This property enables WST11 to release free radicals and kill surrounding cells when exposed to a laser light. Read more
TransEnterix said today that it inked a deal to sell up to $25 million worth of stock to Lincoln Park Capital Fund over 3 years.
Research Triangle Park, N.C-based TransEnterix said the deal values any sales based on its share price at the time. The company markets a robot-assisted surgery platform that incorporates haptics and eye-tracking technology called Senhance. Read more
Stryker subsidiary Sage Products purchased 27 acres of land in Cary, Ill. for $3.4 million, looking to expand its headquarters in the area, according to a Daily Herald report.
Sage makes products for oral care, skin preparation & protection, patient cleaning & hygiene, turning & positioning and heel care. Read more
Lensar Inc. today filed for Chapter 11 bankruptcy protection, saying it needs to reduce its debt and strengthen its balance sheet and platform for future growth.
The Orlando, Fl.-based company was supported by its senior secured lender, PDL BioParhma Inc. Read more