European regulators granted CE Mark approval to California-based medical device startup ReCor Medical for its 2nd-generation Paradise system, which treats drug-resistant hypertension by targeting the renal nerves.
Medical device maker St. Jude Medical (NYSE:STJ) won CE Mark approval in the European Union for its ViewFlex Xtra intracardiac echocardiography catheter for use with the device giant’s ViewMate Z ultrasound console.
The upgraded system offers one-handed use, an ergonomic handle and 4-way tip deflection, according to a press release.
German medical device company eZono AG, which develops portable tablet ultrasound systems, landed $10 miillion funding from MVM Life Science Partners to expand its R&D operations.
In addition, MVM partner Hugo Harrod will join eZono’s board of directors, according to the press release.
Israeli device maker InSightec won FDA approval for its ExAblate MRI-guided focused ultrasound therapy with indication to treat pain resulting from bone metastases in patients who failed or aren’t good candidates for radiation therapy.
Bone metastases occur when cancer cells break off from the primary tumor site and spread to other parts of the body, commonly leaving patients with significant physical and emotional pain, according to a press release.
Farmingdale, N.Y.-based Misonix posted profits of $366,000, or 5¢ per share, on sales of $1.7 million for the 12 months ended June 30 – for a 26.7% top-line gain that helped Misonix swing from a $3.5 million loss during its last fiscal year.
The FDA approved U.S. studies of Israel-based InSightec’s ExAblate Neuro in treatment of medication resistant Parkinson’s disease.
InSightec will enroll 30 patients who suffer from tremors associated with the disease, randomizing them for treatment with ultrasound-based deep-lesioning of the brain.
MASSDEVICE ON CALL — Physicians may be relying too heavily on drug-eluting stents for patients who aren’t at significant risk of restenosis, a preference that could represent an unnecessary financial burden on the healthcare system, a new study suggests.
Opting for less expensive bare-metal stents for patients whose blood vessels aren’t at high risk of re-narrowing could save hundreds of millions of dollars per year without significantly increasing patients’ risk of requiring a repeat procedure, according to a retrospective study of the National Cardiovascular Data Registry CathPCI .