The Institute of Medicine’s report on the FDA’s 510(k) clearance process for medical devices falls so far out of the scope of the questions it was meant to answer that it’s essentially meaningless, med-tech industry reps told the agency during negotiations over re-authorizing the Medical Device User Fee & Modernization Act.
MASSDEVICE ON CALL — Singapore’s Awak Technologies Pte. has cut a dialysis machine down to the size of a purse with its portable, wearable artificial kidney.
The product is undergoing animal and lab tests in Singapore and the company hopes to submit data for European and U.S. regulatory review in 2013.
Several U.S. companies are simultaneously developing their own wearable hemodialysis machines, but none have yet hit the market, the Wall Street Journal reported.
Medsquire LLC slapped 14 companies, including some of corporate America’s biggest names, with a patent infringement lawsuit covering electronic medical records systems.
Abbott Laboratories (NYSE:ABT) landed FDA approval for a new testosterone-boosting product.
The company’s AndroGel 1.62% is treatment for male low testosterone levels, also know as hypogonadism, which affects nearly 14 million men in the United States, according to the company.
Madison, N.J.-based Quest won an early termination of the premerger review from the FTC, bringing the company another step closer to acquiring the Worcester, Mass.-based laboratory, which specializes in genetic testing for neurological disorders.
Personalized medicine test maker AssureRx Health completed an $11 million Series B round.
The Mason, Ohio-based company plans to use the funding to expand sales and marketing for its GeneSightRx test, which helps doctors pick the right psychiatric drugs for patients based on their genes. The company launched the test in 2009.
AssureRx also intends use the investment to develop an unspecified second product, according to the company.
The FDA granted Boston Scientific Corp. (NYSE:BSX) approval for its anchoring device for the company’s spinal cord stimulator (SCS) implant system.
The Natick, Mass.-based medical device giant designed its new Clik Anchor with locking system to increase the speed with which surgeons place the Precision Plus SCS system’s leads — the wires through which pain-masking electrical pulses are delivered to the spine for chronic pain management.
MASSDEVICE ON CALL — The Mass. Life Sciences Center, a quasi-public agency that oversees state dollars allocated toward increasing the life sciences industry’s footprint in the Bay State, doled out another $3.8 million in “accelerator” loans.
The program is designed to provide a boost to early-stage life science companies that the center’s scientific advisory board deems to have a high potential for commercialization, rapid growth and the ability to raise substantial capital.
Sterigenics International Inc. is changing private equity ownership for $675 million.
Chicago-based firm GTCR LLC entered into a deal to buy the sterilization and ionization services company from fellow Chicagoans PPM America Capital Partners and Europe-based Silverfleet Capital.
The companies expect the deal to close by the end of the second quarter of 2011.