E.U. scrutinizes medtech review “shopping” | MassDevice.com On Call

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MASSDEVICE ON CALL — Under fire for being too lenient with medical device approvals, European regulators proposed an update to current CE Mark review and approval practices.

Specifically, the European Commission’s proposed changes address the relative ease with which companies can secure CE Mark approval by "shopping" for an agency in a specific country that will most quickly green-light a new device.

The new proposal would scrutinize private companies that currently help guide approvals, homogenize the approval process among countries and increase pre-market information transparency between countries, according to QMed.

 Magnetic stimulation might "completely" treat depression
Data from a London Psychiatry Center study concluded that 6 out of 10 of patients with serious, treatment-resistant depression recovered "completely," achieving complete remission after being treated with a repetitive transcranial magnetic stimulation (rTMS).

"These data reinforce the body of existing worldwide evidence for rTMS and its proven ability to treat depressed patients who have not responded to drug treatment and/or therapy," according to psychiatry center consultant Dr Rafael Euba.
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 Medical Device Act in Malaysia cracks down on unregistered products
Malaysia’s Medical Device Act is rolling out this month, and Health Minister Datuk Seri Dr S. Subramaniam
said registration of some 70,000 medical devices is underway. The country has been inundated with untraceable medical technologies and the new registration policy is part of an effort to confirm devices in use are safe.
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 Medicare still hasn’t collected $543M in overpayment
A report from the office of the inspector general of the Dept. of Health & Human Services said CMS has failed to collect $543 million in over-payments thanks to a problem with its accounting system, and the funds may be unrecoverable.
Read more

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