Health care reform: Medicare overhaul isn’t settled yet

MassDevice On Call

MASSDEVICE ON CALL — Despite an electoral setback, Republicans aren’t backing down on their controversial plan to overhaul Medicare.

New York’s traditionally Republican district elected Democrat Kathy Hochul to the U.S. House. Republicans responded by vowing to renew their ardor for Medicare reform.

The Republican plan, authored by Rep. Paul Ryan (R.-Wis.), would transform Medicare into a voucher system for those under 55 years old.

Democrats countered by saying the Ryan plan would shift health care costs to seniors and people with disabilities. "[Democrats] are shamelessly demagoguing and distorting it," Ryan told the Wall Street Journal.

The measure, which passed the House, failed in the Senate on a 57-40 vote yesterday. No Democrats voted for the plan; five Republicans crossed the aisle to oppose it.

Research finds altered brain structure among autistic patients.

The temporal and frontal lobes of the brains of people with autism are more similar than those without the syndrome, according to a new study from UCLA.

Those two brain lobes are usually easy to discern, thanks to hundreds of genes that behave differently from region to region. The study considered the brains of 19 autistic patients, looking for patterns that might hint at the underlying mechanism of autism. The research is the first to reveal how the disorder works at the molecular level, altering brain structure through gene expression.

The findings support the theory that changes in the brain lead to autism, rather than the other way around, according to principal investigator Dr. Daniel Geschwind.

Medical Record Bank wins patent for online electronic medical record system

The U.S. Patent and Trademark Office issued a patent to Boston-based Medical Record Bank Inc. for a “patient-centric technology for medical record centralization.” The system allows patients and doctors to access patient-labeled and authenticated chronological medical histories, offers patient health care diaries and maintains critical health information summaries.

The system collects patient data from all healthcare providers the individual may be involved with, and allows the consumer to control their information with an interface that is "as easy to use as e-mail," according to a release.

Angiodynamics prepares for NanoKnife trials, cuts LC Bead distribution

After the Food & Drug Administration warned AngioDynamics Inc. (NSDQ:ANGO) for some allegedly over-zealous marketing of its NanoKnife system early this year, the company won IDE approval to test the device for the ablation of low-risk localized prostate cancer. The FDA’s approval is for a total of six patients at up to three sites in the U.S. to provide a basis for additional trials.

The Latham, N.Y.-based company also announced the expiration of its contract with BTG plc (LSE:BGC) for U.S. distribution of the LC Bead embolization device, which represented approximately 13 percent of AngioDynamics’ net sales through the first nine months of FY2011, according to a release.

Just do it: Covington senior counsel says FDA and 510(k) are flawed, but unavoidable

The FDA’s procedures may be frustrating, but there’s no way around them, senior counsel for Covington & Burling Peter Barton Hutt argued during a panel at the InHealth 510(k) Survey Results conference in D.C. yesterday.

Hutt, who counsels medical device makers on the regulatory labyrinth, broke his advice into two phases.

: "Step one, find out what FDA wants. Step two—do it. It doesn’t matter if what they ask for is stupid or brilliant. It doesn’t matter if the request is reasonable. If you don’t give FDA what they ask for, you aren’t going to get your device approved," said Hutt, who was seated immediately to the left of Dr. Jeffrey Shuren, head of the FDA’s medical deice arm.

Shuren said he liked Hutt’s Law, with one caveat: The FDA’s requests must be grounded in good science.

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