Medtronic Inc. (NYSE:MDT) won FDA clearance for its next generation iPro2 Professional continuous glucose monitor.
The iPro2 Professional is a clinician-owned device that collects glucose data from a sensor inserted into a patient’s skin.
The device tracks the patient’s glucose levels for 3 days, collecting data as many as 288 times each day. The information may provide insight into how diet, medication and daily activities affect a patient’s glucose levels.
"I find it particularly helpful in identifying repeated glucose lows at night and glucose highs after meals," University Diabetes & Endocrine Consultants’ Dr. David Huffman said in prepared remarks. "I am one doctor in a busy office, but the advances with iPro2 will make Professional CGM accessible to more patients who need it. I see that as better medicine."
Professional CGM is ideal for patients with Type I or Type II diabetes who have are persistently unaware of extreme highs and lows in their glucose levels, according to a published consensus from the American Assn. of Clinical Endocrinologists. The clinician-led process was also recommended for pregnant women and youth with Type I diabetes.
Proper glucose control may help patients avoid complications associated with diabetes, including blindness, kidney failure, amputation, impotence and heart disease, according to a press release.
"CGM adoption is on the rise," Medtronic VP and general manager for the continuous glucose monitoring business Greg Meehan said in prepared remarks. "We believe the combination of improved reimbursement for both clinicians and patients, increased clinical evidence as seen in the Medtronic STAR 3 and JDRF trials, as well as ongoing product advancements, are moving CGM devices toward the standard of care for diabetes management."
Medtronic announced approval of its AdaptiveStim with RestoreSensor neurostimulation system, the first and only chronic pain treatment that harnesses motion sensor technology found in smart phones and computer gaming systems to provide effective pain relief and convenience by automatically adapting stimulation levels.
Read more
IntriCon Corporation (NSDQ: IIN), developer of miniature and micro-miniature body-worn devices, received 510(k) clearance for its Sirona Event and Holter Recorder, the company’s second-generation cardiac diagnostic monitoring device, allowing physicians to monitor patient cardiac events remotely .
Read more
SonoSite Inc. (NSDQ:SONO) received FDA 510(k) clearance for its fifth-generation Edge ultrasound system.
Read more
Staar Surgical Co., which designs, develops, manufactures and markets implantable lenses for the eye, received CE Mark approval in the European Union for its nanoFLEX Toric Collamer Single Piece intraocular lens.
Read more
The IsoFlow Infusion Catheter, from Vascular Designs Inc., received CE Mark approval for use in Europe and Canada.
Read more
Neovasc Inc. (NYSE: NVC) received CE mark approval for its Reducer product, which was developed to treat refractory angina.
Read more
BSD Medical Corp. (NSDQ:BSDM) obtained humanitarian device exemption marketing approval for the BSD-2000 Hyperthermia System.
Read more
Dendreon Corp. (NSDQ:DNDN) today announced the Centers for Medicare & Medicaid Services updated their coverage policy to now cover the infusion costs associated with the administration of Provenge.
Read more
Retina Implant AG announced that its scientific advisory board is in full support of beginning the multi-center phase of the company’s second human clinical trial for subretinal implants for retinitis pigmentosa patients.
Read more
IsoRay Inc. (AMEX: ISR) received final approval from the State of Washington Department of Health to manufacture its GliaSite radiation therapy system, a balloon catheter device used in the treatment of brain cancer.
Read more
Canon U.S.A. Inc. announced that the Canon CXDI-80C Wireless Digital Radiography Detector, along with the CXDI-501 Series DR Detectors, received 510(k) clearance.
Read more
CerMed International, an international women’s medical device company, announced that it received CE Mark approval for CerMap, its advanced Cervical Specimen Collection Device used in cervical cancer screening procedures.
Read more
Translational Sciences Corporation received FDA 510(k) clearance for commercialization of its OncoTrac medical imaging software.
Read more
Merz Aesthetics today announced that the FDA cleared the Belotero Balance device for the correction of moderate-to-severe facial wrinkles and folds.
Read more
