1. India approves Accuray’s Radixact X9 radiation therapy device
Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in India for its Radixact X9 System. The approval allows the company to sell the TomoTherapy platform while allowing hospitals throughout India to import the system. The Radixact and TomoTherapy Systems are radiation therapy devices that can deliver treatment from both clinician-specified bean angles and by continuous delivery of radiation from 360º around the patient. The Radixact System can be used for a number of cases including large tumors or multiple tumors throughout the body, standard radiation therapy indications like breast, lung, prostate and head and neck cancers, as well as complex treatments like total marrow irradiation and whole-brain with simultaneous boosts to multiple metastases.
2. FDA clears Tenon Medical’s Catamaran sacroiliac fusion device
Tenon Medical has received FDA 510(k) clearance for its Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), according to a June 20 press release. The CAT SJI Fixation System is designed for sacroiliac joint fusion for conditions such as sacroiliac joint disruptions and degenerative sacroiliitis. Tenon Medical’s system allows surgeons to use a navigated procedure or fluoroscopic imaging for flexibility in access and visibility. It is designed to allow for bone graft materials to be loaded and delivers to the SIJ before and after implant to promote SIJ fusion.
3. BTG inks deal with pulmonary embolism consortium
BTG announced in a June 21 press release that it has forged a strategic partnership with PERT Consortium to advance research of pulmonary embolism treatment while promoting the implementation fo PERT programs across the U.S. Through the partnership, BTG hopes to improve patient care and reduce in-hospital mortality that is associated with pulmonary embolism.
4. Arcuro Medical wins FDA nod for SuperBall knee treatment
Arcuro Medical has received regulatory clearance from the FDA for its SuperBall meniscus repair system, according to a June 18 press release. The all-suture meniscus repair system preserves knee functionality. It allows surgeons to repair the meniscus instead of removing it to fix meniscus tears and maintain knee functionality.
5. NuSight launches NuLid dry eye device
NuSight announced in a June 20 press release that it has launched its NuLids System in the U.S. The system is a doctor-prescribed, home-use medical device that treats dry eye by gently stimulating, de-capping and rejuvenating the Meibomian glands in the eye. In clinical studies, the system showed a 65% improvement in tear breakup time and an 81% improvement in Meibomian glands yielding liquid secretions. Most of the patients in the studies reported having a two-fold improvement in dry eye symptoms after two weeks of treatment.
6. TransMed7 wins FDA nod for SpeedBird soft tissue biopsy devices
TransMed7 has received FDA 510(k) clearance for its SpeedBird platform of soft tissue biopsy devices, according to a June 20 press release. The SpeedBird platform is based on the company’s Zero5 work element that has a fused, single element that is constructed from 3 hypotubes and forms rotating twin cutter blades. The element is able to core, sever and provide a pathway to transport multiple tissue samples through a closed-circuit flush and vacuum mechanism into a detachable chamber. It can be fully-automated or manually operated and is a hand-held, ultrasound-guided, single insertion, multiple sample device. The SpeedBird platform is designed to address issues associated with current biopsy devices, including difficulty visualizing the needle tip with real-time imaging, sharp and potentially traumatic needle tips, limitations in biopsy specimen and tissue type and needle gauge restrictions.
7. Masimo, PositiveID release wireless thermometer
Masimo and PositiveID announced in a June 18 press release that it has launched the TIR-1, non-contact Bluetooth-enabled thermometer. The thermometer is designed to integrate seamlessly with the Masimo Root patient monitoring and connectivity platform. TIR-1 us an infrared thermometer that gives forehead temperature measurements. It reduces the chance of cross-contamination and eliminates the need to purchase additional disposables like probe covers.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
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