European Healthcare regulators take a hard look at CE Mark loopholes that allow medical device companies to “shop” for easier pathways to approval.
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).
Terumo strikes a deal with Olympus for its GlideWire urology device, 2 years after spiking a similar...
Tandem Diabetes is taking orders for its new t:flex insulin pump, 4 months after FDA officials...
Iceland's Össur develops bionic implants that allow amputees to control prosthetic limbs with their...
Biolase lures Zimmer Dental president Harold Flynn to be its new CEO.