1. Guardant levels false advertising suit against Foundation Medicine
Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for false advertising and unfair competition. Guardant Health is claiming that Foundation Medicine’s advertising causes harm to Guardant Health and its patients because it misleads oncologists about the sensitivity and accuracy of the Guardant 360 assay and Foundation Medicine’s own assay. The complaint also says that Foundation Medicine promotes its assay as being “best in class” with “unparalleled” sensitivity, even though multiple research proves otherwise. Guardant Health is asking the court to stop Foundation Medicine from making false and misleading claims about its assays and the Guardant360 and wants Foundation Medicine to retract, remove and correct false and misleading advertising claims.
2. FDA clears Meditech Spine’s Talos Lumbar device
Meditech’s Talos Lumbar (HA) Peek IBF spinal surgery device has received FDA 510(k) clearance to be marketed, according to a June 19 press release. The device is an intervertebral body device that is designed to be used in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. The Talos Lumbar Peek IBF device is also designed to be used with autograft and/or allograft that is made of cancellous and/or corticocancellous bone graft.
3. Neurotech company Rythm launches sleep-enhancing device
Neurotechnology startup company Rhythm announced in a June 15 press release that it has officially launched its Dreem sleep solution that monitors, analyzes and acts on your brain to enhance sleep. The device consists of a headband that monitors brain activity and uses auditory stimulation to assist in falling asleep faster and getting a deeper sleep. It also helps users wake up refreshed. The headband consists of dry polymer EEG electrodes while the headband independently analyzes brain activity with an internal CPU. The front of the device has a bone-conduction technology that emits sound directly to the inner ear.
4. TSO3 eyes FDA nod for duodenoscope cleaning
TSO3 announced that it is planning to seek FDA 510(k) clearance for its Sterizone VP4 Sterilizer, according to a June 14 press release. The terminal sterilization of the two duodenoscopes is used in most endoscopic retrograde cholangio-pancreatography procedures performed around the world. TSO3 plans to file with the FDA for both the Olympus TJF-Q180V and Pentax ED-3490TK duodenoscopes starting in July this year. The company hopes to receive FDA clearance by the end of the year. FDA and other regulators have tied duodenoscopes to superbug outbreaks in multiple U.S. states, with better cleaning methods and processes recommended for the scopes.
5. EndoStim launches GERD trial
EndoStim announced in a June 14 press release that it has enrolled the first patients in the GERD trial. The trial involves implanting an EndoStim device in the lower esophageal sphincter stimulation. The trial is being done in collaboration with Dignity Health St. Joseph’s Hospital and Medical Center. The EndoStim system is an implantable device that is minimally invasive and is designed to give patients long-term reflux control by restoring normal function to the esophagus through neurostimulation. The GERD trial will be evaluating the safety and efficacy of the EndoStim Lower Esophageal Sphincter Stimulation system in patients who have gastroesophageal reflux disease.
6. Windtree, Lee’s Pharmaceutical to bring inhaled surfactant platform to Asia
Windtree Therapeutics and Lee’s Pharmaceutical have announced that they have entered an exclusive license and collaboration agreement to develop and commercialize KL4 surfactant products in Asian markets, according to a June 12 press release. Aerosurf and Surfaxin are included in the agreement. Windtree has also granted Lee’s Pharmaceutical an exclusive license to manufacture KL4 surfactant in China to be used in non-aerosol surfactant products.
7. Interson receives 510(k) clearance for ultrasound probes
Interson announced in a June 13 press release that it has received FDA 510(k) clearance to market its SiMPLi Series ultrasound array probes for medical applications. The company’s linear and convex array probes allow medical professionals to use Windows tablets and laptops to display ultrasound images in real-time at a resolution that was previously only available on high-end ultrasound systems. They SiMPLi Series probes are also lightweight, handheld and can be carried to any patient location.