Esophagus

AnX Robotica is Pleased to Announce FDA Clearance for Expanded Indications of NaviCam Small Bowel Video Capsule Endoscopy

Retrieved on: 
Monday, January 15, 2024

PLANO, Texas, Jan. 15, 2024 /PRNewswire/ -- AnX Robotica, the leader in advanced gastrointestinal visualization technologies, is thrilled to announce FDA clearance for expanded indications of its NaviCam Small Bowel Video Capsule Endoscopy (SB) in both adults and children aged 2 years and above.

Key Points: 
  • PLANO, Texas, Jan. 15, 2024 /PRNewswire/ -- AnX Robotica, the leader in advanced gastrointestinal visualization technologies, is thrilled to announce FDA clearance for expanded indications of its NaviCam Small Bowel Video Capsule Endoscopy (SB) in both adults and children aged 2 years and above.
  • This significant milestone, combined with the recent FDA clearance of ProScan, the pioneering AI-assisted reading tool for Small Bowel Video Capsule Endoscopy (VCE), firmly establishes NaviCam SB as the most advanced technology in small bowel vide capsule endoscopy.
  • In tandem with the NaviCam SB clearance, the FDA has also approved the NaviCam Tether as an accessory for the NaviCam SB Capsule.
  • "With FDA clearance, NaviCam Small Bowel Capsule Endoscopy represents a groundbreaking leap forward, now extending its revolutionary diagnostic capabilities to patients as young as 2 years old.

Castle Biosciences Announces Preliminary Fourth Quarter and Full-Year 2023 Results

Retrieved on: 
Monday, January 8, 2024

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced certain unaudited preliminary performance results for the fourth quarter and year ended Dec. 31, 2023.

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced certain unaudited preliminary performance results for the fourth quarter and year ended Dec. 31, 2023.
  • DecisionDx®-SCC test reports delivered in the quarter were 3,530, compared to 1,845 in the fourth quarter of 2022, an increase of 91%.
  • TissueCypher® Barrett’s Esophagus test reports delivered in the quarter were 3,441, compared to 1,030 in the fourth quarter of 2022, an increase of 234%.
  • Castle Biosciences has not completed the preparation of its financial statements for the fourth quarter or year ended Dec. 31, 2023.

FDA Grants Breakthrough Device Designation for Geneseeq's Multi-cancer Early Detection Solution

Retrieved on: 
Wednesday, January 3, 2024

TORONTO, Jan. 3, 2024 /PRNewswire/ - Geneseeq announced that its multi-cancer early detection solution, CanScan™, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).

Key Points: 
  • TORONTO, Jan. 3, 2024 /PRNewswire/ - Geneseeq announced that its multi-cancer early detection solution, CanScan™, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).
  • The test outperforms current standard of care (SOC) screening methods in common cancer types, such as prostate, lung and liver cancers.
  • It also detects cancer types currently without effective SOC screening methods, such as esophagus, endometrial, gastric, pancreatic cancers and lymphoma.
  • This FDA Breakthrough Device Designation follows the CanScan™ assay kit's CE approval in January 2023, marking another significant recognition from an internationally authoritative institution.

Global Capsule Endoscopy Market Research Report 2023: Disease Type, Product, End Use, & Region Insights and Forecasts with Potential Impact of COVID-19 2022-2027 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, January 3, 2024

The "Global Capsule Endoscopy Market (by Disease Type, Product, End Use, & Region): Insights and Forecast with Potential Impact of COVID-19 (2022-2027)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Capsule Endoscopy Market (by Disease Type, Product, End Use, & Region): Insights and Forecast with Potential Impact of COVID-19 (2022-2027)" report has been added to ResearchAndMarkets.com's offering.
  • The global capsule endoscopy market is expected to reach US$559.59 million in 2023, growing at a CAGR of 8.64% during the forecast period.
  • The range of applications for capsule endoscopy systems, including those for colon disease, small bowel disease, and esophageal illness, has increased due to technological developments.
  • Global Capsule Endoscopy Market Players: Financial Comparison
    Global Capsule Endoscopy Market Players: R&D Expenses Comparison

The Inner Circle Acknowledges, Allan Lamb as a Pinnacle Platinum Healthcare Professional

Retrieved on: 
Friday, December 29, 2023

TRENTON, Mich., Dec. 29, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Allan Lamb is acknowledged as a Pinnacle Platinum Healthcare Professional for his contributions to the fields of General Surgery and Osteopathic Medicine.

Key Points: 
  • TRENTON, Mich., Dec. 29, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Allan Lamb is acknowledged as a Pinnacle Platinum Healthcare Professional for his contributions to the fields of General Surgery and Osteopathic Medicine.
  • Dr. Lamb pursued higher education at Earlham College in 1989 where he earned a Bachelor of Arts degree.
  • He then attended Des Moines University College of Osteopathic Medicine in 1995 and received a Doctor of Osteopathic Medicine degree.
  • Dr. Lamb currently serves as an osteopathic physician and the President of Lakeshore Surgical Consultants PLC in Trenton, Michigan.

EsoCap reports positive topline results from ACESO Phase II trial investigating ESO-101 in eosinophilic esophagitis

Retrieved on: 
Tuesday, December 5, 2023

The ACESO study is a randomized, placebo-controlled, double-blind Phase II study to evaluate the efficacy, tolerability and safety of ESO-101 in patients with active eosinophilic esophagitis (EoE).

Key Points: 
  • The ACESO study is a randomized, placebo-controlled, double-blind Phase II study to evaluate the efficacy, tolerability and safety of ESO-101 in patients with active eosinophilic esophagitis (EoE).
  • "The ACESO study represents an important milestone in the development of our unique application platform for the treatment of esophageal diseases.
  • Following the successful results of this Phase II study, we now plan to initiate a Phase III program in eosinophilic esophagitis,” said Isabelle Racamier, CEO of EsoCap.
  • The detailed results from the ACESO study, including secondary endpoint data, will be submitted for presentation at a future scientific conference.

Phathom Pharmaceuticals Announces Commercial Availability of VOQUEZNA® (vonoprazan) Tablets, a Powerful First-In-Class PCAB for the Treatment of Erosive GERD and Relief of Associated Heartburn

Retrieved on: 
Tuesday, November 28, 2023

“We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.

Key Points: 
  • “We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.
  • “Erosive GERD is a highly prevalent condition affecting over 20 million people in the U.S.,3,4 many of whom experience troubling symptoms, including painful heartburn.
  • Phathom is offering programs for eligible patients who face coverage or affordability issues, including co-pay assistance for patients with commercial insurance.
  • for up to 6 months to maintain healing of Erosive Acid Reflux and for relief of heartburn related to Erosive Acid Reflux.

Kansas City Proton Institute Begins Cancer Treatments with Advanced MEVION S250i Proton Therapy System

Retrieved on: 
Friday, December 22, 2023

Kansas City Proton Institute (KCPI), the first physician-led proton therapy center in the Midwest, and Mevion Medical Systems announced today that the first four patients were treated at Kansas City Proton Institute on Dec. 19, with the MEVION S250i Proton Therapy System® .

Key Points: 
  • Kansas City Proton Institute (KCPI), the first physician-led proton therapy center in the Midwest, and Mevion Medical Systems announced today that the first four patients were treated at Kansas City Proton Institute on Dec. 19, with the MEVION S250i Proton Therapy System® .
  • (Photo: Business Wire)
    Kansas City Proton Institute recently opened the doors to its new facility that houses the region’s first Mevion compact proton therapy system.
  • The MEVION S250i system at KCPI also integrates an advanced 3D imaging system and will install the C-RAD Catalyst PT surface-guided tracking system, enabling a cutting-edge Image-Guided Proton Therapy configuration for high-precision patient positioning and intra-fraction motion management.
  • “We congratulate Kansas City Proton Institute for starting treatment with the Mevion proton therapy system,” said Tina Yu, PhD, chief executive officer and president of Mevion Medical Systems.

Motus GI Announces First Upper GI Patient Procedure for FDA Cleared Pure-Vu® EVS Gastro

Retrieved on: 
Friday, November 10, 2023

FORT LAUDERDALE, Fla., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Motus GI Holdings, Inc. (NASDAQ: MOTS) (“Motus GI” or the “Company”), a medical technology company focused on improving endoscopic outcomes and experiences, announced today that the Pure-Vu® EVS Gastro was successfully used in the first procedure since receiving FDA clearance. The case was completed by Dr. Brian Hanson, Gastroenterologist and Associate Professor of Medicine, University of Minnesota.

Key Points: 
  • “It is exciting to clear the first procedure milestone so soon after receiving FDA clearance.
  • We look to forward to implementing the planned U.S. market introduction of the Pure-Vu EVS Gastro.
  • I was able to normally retroflex the scope with the Pure-Vu EVS Gastro attached, and use irrigation to clear the field of view,” commented Dr. Hanson.
  • Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases per year in 2019, according to iData Research Inc.

Rapid Growth at Attune Medical Spurs Strategic Hires and Expansion

Retrieved on: 
Thursday, December 14, 2023

Attune Medical, a pioneer in utilizing the esophageal space to proactively manage patient temperature and to reduce the likelihood of esophageal injury during cardiac ablation procedures, announces significant growth with three key additions and expansion of commercial operations.

Key Points: 
  • Attune Medical, a pioneer in utilizing the esophageal space to proactively manage patient temperature and to reduce the likelihood of esophageal injury during cardiac ablation procedures, announces significant growth with three key additions and expansion of commercial operations.
  • (Graphic: Business Wire)
    Melinda Smith, MS, RAC, CBA, joins Attune Medical as VP of Regulatory Affairs leading our global regulatory strategy.
  • In her role with Attune Medical, she will expand efforts in clinical research and study start-up while managing high-profile NIH funded clinical trial efforts.
  • In addition, the company is actively expanding its commercial and clinical teams to accommodate the rapid growth it is experiencing.