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BioSphere Medical inks Japanese distribution deal

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BioSphere Medical Inc. inked a deal with Nippon Kayaku Co. Ltd. to distribute two of its products in Japan.

The Rockland-based biotech firm said Nippon Kayaku will distribute its HepaSphere and Embosphere products, tiny “microspheres” used in embolotherapy procedures to treat uterine fibroids, hyper-vascularized tumors and vascular defects.

The terms of the deal call for the Japanese firm to handle and pay for the regulatory process there, “including performing any clinical studies that may be required as a condition to product registration.”

Orthofix named in a false claims complaint—again

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Orthofix International is one of the companies named in a whistleblower lawsuit accusing the group of bone-growth stimulator manufacturers of reimbursement fraud.

It’s not the first time the Boston-based orthopedics maker has run afoul of federal authorities and the False Claims Act. In 2003, the company agreed to pony up nearly $1.6 million to settle allegations that it submitted false claims to TRICARE, the military’s healthcare program.

Are VC funds really the same thing as hedge funds?

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What is the basic goal of venture capital? The answer is generally pretty straightforward: Trade cash for equity in companies with the hope of realizing outsized returns on those investments.

Isn’t that pretty much what hedge funds do? If both groups try to do the same thing, then shouldn’t they be regulated the same way?

I think this must have been U.S. Treasury Secretary Timothy Geithner’s line of reasoning during his recent testimony before Congress.

Cynosure cuts staff, braces for heavy losses

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Cynosure Inc. is bracing for another hard landing after predicting a 60 percent revenue plunge for the first quarter of 2009.

The sales drop pushed the Westford-based cosmetic laser products maker into the red and forced officials to lay off 25 employees, about 10 percent of its total workforce.

CEO Michael Davin said the cuts were offset by the addition of 11 employees hired to open a direct sales office in Korea; accounting for the layoffs and new hires, the company has 271 workers worldwide, down from 288 at the end of 2008.

FDA issues worldwide recall for Teleflex Medical balloon pump catheter

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The Food and Drug Administration issued a Class 1 recall for one of Teleflex Medical‘s balloon pump catheters, due to a problem with the device’s electronic volume setting.

The federal watchdog agency said it received 25 complaints, but no reports of injuries, about a problem it described as a faulty volume connection for the Everett-based company’s 30cc, 40cc and 50cc Intra Aortic Balloon Pump catheters made by its Arrow International subsidiary.

American Well lands second BCBS contract

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American Well landed its second contract with Blue Cross, Blue Shield, this time to provide its Online Care service to the healthcare provider’s Minnesota operation.

The Boston-based online healthcare services provider‘s first deal, inked last year, was with the healthcare provider’s Hawaii operation.

Online Care is a multimedia web interface that allows patients to virtually consult with physicians over the Internet.

Medicare eases PET scan coverage rules

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On April 3, the Centers for Medicare & Medicaid Services published a decision memorandum announcing significant easing of its coverage requirements for Positron Emission Tomography (PET) testing of solid tumors and myeloma. A minimally invasive diagnostic imaging procedure, PET uses a radioactive tracers to evaluate glucose metabolism in tumors and in normal tissue.