FDA approves Dexcom smartphone-enabled device, Dexcom Share, for continuous glucose monitoring
Dexcom was cleared by the FDA for the Dexcom Share, an add-on to its Dexcom G4 Platinum continuous glucose monitoring device that wirelessly transmits patients’ glucose levels through a smartphone using Bluetooth technology. Patients can then upload the information through the app and choose up to 5 recipients to receive the data. The recipients can then track the information through either an Apple computer or an Apple mobile device.
Illumina is up 10% on strongest its growth since 2011, and raises its 2014 guidance
Illumina achieved a revenue growth of 35% to $481 million during the third quarter compared to the same quarter a year ago. With the news of the revenue growth, Illumina raised its 2014 revenue growth guidance to about 30%, from the previously stated 25% to 26%. The company’s CEO Jay Flatley attributed the revenue’s outstanding growth rate to the record growth of 47% year-over-year in sequencing consumables and an increase in sequencing instrument revenue of 55%.
Bio-artificial pancreas undergoing new trial
Researchers are working on a new implantable device that encapsulates and nurtures pancreatic beta cells which will hopefully provide sufficient insulin to Type 1 diabetes patients. The first patient in an 8-patient clinical trial has already been implanted with the βAir Bio-Artificial Pancreas from startup Beta-O2. The startup expects that the device will address three crucial hurdles for a bio-artificial pancreas implant: avoiding rejection without a lifetime of immunosuppressive drugs, providing sufficient oxygen to the pancreatic cells to keep them functioning well, and offering sufficient quantities of insulin to the patient.
Google, KKR, and Kleiner Perkins have invested $542M in a virtual reality eyeglass startup
Magic Leap received $542 million in funding to develop its innovative eyeglasses-like device that could potentially provide a new interface for patient-doctor communication. The Dania, FL-based startup brought in funds from Google, private equity firm KKR, and venture capital firm Kleiner Perkins to roll out virtual-reality goggles that project two different images onto the eyes, allowing users to see 3-D objects. What sets Magic Leap’s goggles apart from virtual-reality goggles with stereoscopic imaging is their ability to create a sense of depth without triggering nausea, according to the company.
Siemens is in talks to sell its hearing aids business for over $2.6 billion
On the heels of Siemens’ sale of its microbiology and healthcare IT units, the company is contemplating a sale of its hearing aid unit to private equity firm EQT Partners AB for over $2.6 billion. With the recent acquisition of two energy businesses for a combined $8.9 billion, Siemens appears to be focusing more on energy as it aims to improve profitability. And back in May the company announced that it’s managing its entire healthcare business as a standalone entity, leading to speculation that the entire division will be sold off.
The Department of Homeland Security is going to weigh in on device cybersecurity
Amid growing concern over the cybersecurity of medical devices, the U.S. government is weighing in on the issue and investigating two dozen cases of suspected cybersecurity flaws in devices and hospital equipment. The U.S. Department of Homeland Security is reviewing products made by med tech companies such as Hospira, Medtronic and St. Jude Medical to identify and fix vulnerabilities that could leave the devices open to attack.
C.R. Bard Q3 earnings up 41% as it focuses on the launch of its Lutonix Catheter
The Lutonix Drug Coated Balloon Catheter, which was recently cleared by the FDA on October 10 and cleared back in 2012 in Europe, helped generate a 9% increase in the company’s line of peripheral percutaneous transluminal angioplasty devices. The device has been in use in operations in the U.S. since the day after it was cleared by the FDA. For the quarter, the company reported earnings of $131.3 million (up 41% year-over-year) on net sales of $830 million (up 9%).
Mobile blood glucose monitor startup Telcare gets $32.5 million in funding
Telcare received $32.5 million in a Series C round. The company claims its wireless blood glucose monitor is the “first FDA-cleared cellular blood glucose meter.” It transmits data to mobile devices, even in the absence of a Wi-Fi connection, shares the data with a physician, and provides data-analysis tools.
Edwards profit is up 23%, but CEO is concerned about TAVR competition
Edwards Lifesciences beat earnings expectations with faster-than-expected growth in the company’s core market of transaortic valve replacements. But company officials stressed that competitors like Medtronic and St. Jude Medical are ramping up their efforts in that arena following recent product launches. Edwards’ transaortic valve replacement, the Sapien TAVR, recorded a year-over-year sales increase of 55% to $267.2 million, however the CEO does not believe that growth rate is sustainable due to competitors entering the scene.
MusicGlove launches music-based device for stroke rehabilitation
Physical therapy to help stroke patients regain hand motor function after a stroke is extremely repetitive. So repetitive, that many patients struggle to follow through with their therapy. MusicGlove, however, has created a device to combat this dull repetitiveness. They’ve created a sensorized glove that allows users to play a therapy-based music game. It requires patients to complete specific hand movements such as a pincer grasp and a key pinch grip in tandem to scrolling notes on a touchscreen console. The developers compared it to the video game “Guitar Hero.” After using the gloves, patients reported greater ability to turn doorknobs, type, wash dishes, use silverware, and bathe.