NinePoint Medical said today that it won FDA 510(k) clearance for the Intelligent Real-time Image Segmentation software upgrade for its flagship Nvision VLE imaging system. The newly cleared IRIS is an artificial intelligence-based platform for image feature segmentation, the Bedford, Mass.-based company said. The company touted that the approval was the first of its kind for […]
ValenTx raises $10.3 million for implantable gastric bypass device
Startup ValenTx has attracted nearly $10.3 million from 32 investors, according to a filing with the Securities & Exchange Commission. The Maple Grove, Minn. company is developing a removable gastric bypass device as an alternative to Roux-en-Y gastric bypass surgery. It raised $10,271,050 in the round begun July 18, 2018. The ValenTx endoluminal bypass therapy mimics the attributes of […]
Lumendi wins CE Mark, launches DiLumen EIP in EU
Lumendi said today it launched its DiLumen endolumenal interventional platform endoscope sleeve after winning CE Mark approval in the European Union for the device. The Buckinghamshire, U.K.-based company said its DiLumen EIP is a non-sterile, single-use sleeve designed to fit over standard endoscopes to stabilize the devices in the large intestine. Lumendi touted that the device […]
EndoGastric Solutions adds $31m
EndoGastric Solutions, which last week reported raising more than $25 million, said today that the total raise was $30.5 million. Redmond, Wash.-based EndoGastric Solutions said the round was led by existing backers Advanced Technology Ventures, Canaan Partners, Canepa Healthcare, Chicago Growth Partners, CRG, Radius Ventures, Sightline Partners and “several new healthcare investors excited about EGS’ commercial […]
Pulmonx wins FDA approval for Zephyr endobronchial valve
The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema. Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The […]
Apollo Endosurgery wins expanded FDA nod for OverStitch Sx system
Apollo Endosurgery said today it won special FDA 510(k) clearance for its OverStitch Sx endoscopic suturing system, an accessory for its already cleared OverStitch Sx system intended to simplify attachment of the device to compatible endoscopes. The Austin, Texas-based company said that the special clearance is the last regulatory nod it needed before it could introduce […]
7 medtech stories we missed this week: June 22, 2018
From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 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 […]
Apollo Endosurgery prices $21m offering
Apollo Endosurgery today priced a stock offering worth nearly $21 million for its line of bariatric and gastrointestinal devices. Austin, Texas-based Apollo said it plans to float roughly 3.75 million shares at $5.50 apiece, for gross proceeds of $20.6 million. The offering also includes a 45-day option for underwriter Craig-Hallum Capital of another 562,055 shares, […]
Bronchoscopes still dirty after cleaning, study says
A new study has found that currently acceptable methods of reprocessing reusable bronchoscopes left most devices contaminated and damaged. “The results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune-suppression due to malignancy or chronic disease,” said the study, funded by 3M and […]
7 medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press release that it has received FDA 510(k) clearance for its Ingenia […]
Lumendi wins FDA nod for DiLumen IS endoscopic scissors
Lumendi said today it won FDA 510(k) clearance for its DiLumen IS endolumenal interventional scissors, now indicated for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures. The Westport, Conn.-based company touted the sterile, single-use disposable, monopolar electrosurgical device as the fourth it’s developed, and said that it and its recently cleared DiLumen […]
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