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Second state AG subpoenas Medtronic

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Medtronic Inc. (NYSE:MDT) said California attorney general Jerry Brown is demanding documents from its cardiac rhythm management business, making Brown the second AG this year to subpoena the Minneapolis medical device monolith.

Medtronic said Brown wants documents “relating to the Company’s cardiac rhythm medical devices, including revenue, sales, marketing and promotional documents,” according to a regulatory filing. The Golden State’s top legal eagle also wants reimbursement records, clinical trial data and registration information and records of any payments “or items of value” to customers. Brown sent the subpoena Sept. 16, according to the filing.

AdvanDx wins FDA 510(k) clearance for staph test

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AdvanDx won 510(k) clearance from the Food & Drug Administration for a rapid diagnostic designed to detect staphylococcal pathogens in the bloodstream in 90 minutes.

The Woburn, Mass.-based diagnostics maker said the FDA cleared its S. aureus PNA FISH and S. aureus/CNS PNA FISH tests, claiming they cut down turn-around times by an hour by reducing probe hybridization times. Staph bacteria are the most prevalent cause of bloodstream infections and blood culture contamination, according to the company.

BL Healthcare converts loan obligations into $800,000

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BL Healthcare Inc. raised $800,000 by converting bridge loans from original investors into equity and is looking to add to the pot.

The Foxborough, Mass.-based company, which makes a platform that enables healthcare providers to manage and educate their patients through their televisions, said it will use the funds to improve its balance sheet and increase its product portfolio. All but one of the company’s original investors converted debt into equity, according to a company spokesman.

BL Healthcare’s Series A round is open until Dec. 31 and the company is hoping to attract additional investors.

TransMedics drums up $3.6 million in another debt sale

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TransMedics Inc. drummed up $3.57 million from 13 unidentified investors in another debt offering, according to a filing with the federal Securities and Exchange Commission.

The Andover-based firm is developing a system to keep organs viable outside the body until they can be transplanted. It’s got CE Mark approval for the system in the European Union and is undergoing clinical trials for use in heart transplants in the U.S.

UPDATE: Zoll Medical confirms it’s in the hunt for new headquarters

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Zoll Medical Corp. (NSDQ:ZOLL) isn’t about to pay real estate bubble prices in a bear market, and that’s what’s driving the company’s hunt for new space, according to president Jonathan Rennert.

Rennert confirmed to MassDevice that the company is indeed in the hunt for new digs, saying that Zoll’s been exploring locations in New Hampshire, as reported earlier in the month by the Real Reporter, a newsletter that tracks commercial real estate moves in Massachusetts. The heart of the matter is a looming June, 2011, end date on the company’s current lease in Chelmsford, according to Rennert.

Millstone Medical taps new Memphis leadership

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Millstone Medical Outsourcing tapped a pair of insiders to lead the Memphis-based operation it expanded in April.

The Fall River, Mass.-based inspection and clean room services provider said its sales vice president, Jonathan Tillman, moved from the Scholarship City to Memphis to lead Millstone’s sales and “relationship development” efforts there. Tom Williams, a former program manager in Fall River, will lead day-to-day operations in the Bluff City.

Cyberonics aims to stimulate epilepsy treatment

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For some epilepsy patients, the first shot at treatment is often the best.

About 50 percent of epileptics experience a reduction in seizures after being placed on prescription medication for the first time. The other half of the patient population is often forced to try a number of other possible drug therapies before finding one that works, and even that’s sometimes a long shot. Research suggests that the likelihood of reducing seizures in this “refractory” population goes down significantly after the first treatment fails, leaving physicians and patients trying up to eight or nine different types of medication to stop the debilitating seizures.

Federal judge lays into Medtronic in pacemaker case

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Judge James Rosenbaum didn’t mince a single word in his stinging rejection of a Medtronic Inc. (NYSE:MDT) motion to dismiss a class-action lawsuit concerning defective pacemaker batteries.

In a scathing U.S. District Court for Minnesota decision denying the Minneapolis medical device leviathan’s move, Rosenbaum wrote that Medtronic’s core claim “denies reality” and called its arguments “sophistry.”

CMS shifts coverage on HIV screening

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The Centers for Medicare and Medicaid Services shifted gears on its reimbursement policy for both standard and rapid HIV tests, in an attempt to catch more undiagnosed cases in vulnerable populations.

The national insurer changing a statute to make it easier for people whose behavior puts them at greater risk of contracting the virus to get annual screening.

CMS said it will now reimburse physicians for annual HIV screening for the following populations:

  • Men who have had sex with men after 1975;
  • Men and women having unprotected sex with multiple partners;
  • Past or present injection drug users;

LeMaitre wins conditional FDA nod for feasibility study

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LeMaitre Vascular Inc. (NSDQ:LMAT) won conditional approval from the Food & Drug Administration for a feasibility study of its TAArget thoracic stent graft it calls the Entrust trial.

The Burlington, Mass.-based vascular device maker first submitted its application for an investigational device exemption in May of last year for a study evaluating the safety of the graft, which the FDA deems a “significant risk” device. The agency granted conditional approval for the IDE Dec. 4.