Archives
Hologic Launches New Option for Women With Uterine Fibroids
MyoSure Reach from Hologic will help physicians access and remove hard-to-reach uterine fibroids. Nancy CrottiThe MyoSure Reach Device from HologicA new device introduced at the recent American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting in Washingto...
(May, 2016)
Study: Stronger Regulation Needed for Women's Health Devices
Researchers find that some women's health devices received FDA approval despite weak data.
(May, 2016)
Roche to Distribute Long-Term CGM System from Senseonics
Senseonics has landed a major distribution partner for its recently CE-Mark approved long-term continuous glucose monitoring system.
(May, 2016)
Weight Loss Patients Get Digital Support
Apollo Endosurgery, maker of the FDA-approved Orbera gastric balloon for weight loss, has teamed with Zillion to give patients a digital health support program.
(May, 2016)
Should We Worry about TAVR Durability?
New findings from a two-center, single-arm study show a significant rate of degeneration in implanted transcatheter aortic valves (TAVR) and an estimated 50% degeneration rate within eight years. Is there reason for concern?  
(May, 2016)
What Medtronic's Agreement with Mazor Robotics Means
The promise of robotics in surgery - this time in spinal procedures - gets a boost as the dominant force in spine - Medtronic - hitches its wagon to a small robotics spine player. 
(May, 2016)
What's Behind the Decline in Device Recalls?
Statistics on FDA medical device recalls in the first quarter of 2016 show the lowest number of recalls since 2013. Why?
(May, 2016)
FDA Unveils Its Approach to Infectious Disease Sequencing Diagnostics
The agency has issued draft guidance detailing its oversight of next-gen sequencing devices used to diagnose infectious diseases.
(May, 2016)
Could Rural Patients Lose Access to Durable Medical Equipment?
Dozens of legislators from the House of Representatives back a bill to stall cuts to Medicare reimbursement that could impair rural patient access to wheelchairs, oxygen, and other durable medical equipment.
(May, 2016)
Ultrasound Bladder Scanning Gets Mobile Makeover
An Australian company has received the FDA nod to sell a new ultrasound bladder scanning device that works with an Android tablet and aims to make bladder scanning more accurate and intelligent.Frank VinluanWhen patients have problems voiding their bladders – a condition that could lead to urinary...
(May, 2016)
TransEnterix Shifts Spotlight to ALF-X System
After FDA's disappointing rejection of its SurgiBot System 510(k) submission, TransEnterix is putting the focus on its regulatory efforts for the ALF-X System instead.
(May, 2016)
Parallel Review Here to Stay
CMS confirms that Parallel Review, initially a pilot program intended to shorten the lag between device approval and reimbursement coverage, will be made permanent.
(May, 2016)
HeartWare: It'll Be a New Study for MVAD
HeartWare's next-generation left ventricular assist device MVAD, the subject of a CE Mark trial that was halted last fall, will be studied in a new trial once it is ready to return to the clinic.
(May, 2016)
Modern Medical Coatings Bring Versatility, Multiple Functions
New surface modification technologies are helping OEMs overcome challenges associated with making implantable medical devices. 
(May, 2016)
FDA Approves Medtronic AFib-Detecting Single-Chamber ICDs
Medtronic gains FDA approval for its Visia AF ICDs, single-chamber devices that can identify and monitor episodes of atrial fibrillation.
(May, 2016)
2016 Medical Design Excellence Awards Finalists: Readers' Choice Voting
The jurors have already made their decision, and the winners of the 2016 Medical Design Excellence Awards will be announced at a special ceremony at MD&M East on June 14, 2016.But MD+DI is also giving readers the chance to choose their favorite products. Cast your vote in our...
(May, 2016)
2016 Medical Design Excellence Awards Finalists: Harmonic Osteovue Spine
Harmonic Osteovue SpineThe Harmonic Osteovue Spine Soft Tissue Dissector is an energy device designed as an ultrasonic periosteal elevator for spine procedures that cuts and coagulates up to 2-mm vessels using a three-in-one blade and precise ultrasonic energy to improve hemostasis, reduce muscle co...
(May, 2016)
2016 Medical Design Excellence Awards Finalists: Gemini 810+980
Gemini 810+980The Gemini 810+980 is a dual-wavelength soft-tissue surgical laser featuring 20 W of superpulsed power for faster, gentler tissue cutting; a transparent, electroluminescent display; and LED illumination on the hand piece for improved visibility of the surgical site.Manufacturer: Azena ...
(May, 2016)
2016 Medical Design Excellence Awards Finalists: GastriSail
GastriSailGastriSail, an all-in-one device that allows for sizing, decompression, and leak testing during laparoscopic sleeve gastrectomy procedures, autopositions a tube along the lesser curvature and splays the stomach into natural orientation prior to resection to maintain a nonspiraled stomach p...
(May, 2016)
2016 Medical Design Excellence Awards Finalists: Flex Robotic System
Flex Robotic SystemThe Flex Robotic System allows surgeons to navigate around anatomy with a flexible robotic scope equipped with high-definition vision; once positioned, the scope becomes rigid and allows the surgeon to operate with flexible instruments in hard-to-reach, confined spaces.M...
(May, 2016)
2016 Medical Design Excellence Awards Finalists: AccuCirc
AccuCircThe AccuCirc newborn male circumcision device protects patients from injury during circumcision procedures and was designed specifically to be used in resource-limited areas for HIV prevention.Manufacturer: Clinical Innovations                  &n...
(May, 2016)
2016 Medical Design Excellence Awards Finalists: Surgical Equipment, Instruments, and Supplies
Surgical Equipment, Instruments, and Supplies                    Which devices are worthy of MDEA top honors? Find out at a special awards ceremony June 14, 2016, at MD&M East in New York City.   
(May, 2016)
2016 Medical Design Excellence Awards Finalists: Access Strength
Access StrengthThe Access Strength is a fitness and rehabilitation platform that pairs inclusive equipment with cloud-based software to allow practitioner and patient collaboration, and provide precise data recording with measurable outcomes that can be shared across facilities and networks.Manufact...
(May, 2016)
2016 Medical Design Excellence Awards Finalists: Indego
IndegoThe Indego exoskeleton enables paraplegic individuals to walk by using batteries and motors to provide power to the hip and knee joints and harnessing integrated sensors to detect body position and allow the wearer to control the device through postural chnages.Manufacturer: Parker Hannif...
(May, 2016)
2016 Medical Design Excellence Awards Finalists: Dolores One
Dolores OneThe Dolores One speech enhancement device allows critical care patients to vocalize and communicate verbally in their natural voice without interruption of respiratory treatment.Manufacturer: Dolores Speech ProductsSupply/Design: Round Bridge Inc.            ...
(May, 2016)