MRI frequently underestimates tumor size in prostate cancer
FINDINGSA study led by researchers at theUCLA Jonsson Comprehensive Cancer Center has found that magnetic resonance imaging, or MRI, frequently underestimates the size of prostate tumors, potentially leading to undertreatment.The study authors found that such underestimation occurs most often when the MRI-measured tumor size is small and the PI-RADS score, which is used to classify lesions in prostate MRI analysis, is low.For prostate tumor treatments to be successful, both the MRI size measurement and PI-RADS score must be accurate because they allow physicians to determine precisely where tumors end and where the normal,...
Source: UCLA Newsroom: Health Sciences - January 7, 2021 Category: Universities & Medical Training Source Type: news
CSA Medical Announces Enrollment Milestone in a Mechanism of Action Study utilizing the RejuvenAir(R) System for COPD Patients with Chronic Bronchitis
This study will provide a scientific rationale for the remodeling response and clinical improvements identified in the feasibility study BOSTON, Nov. 11, 2020 -- (Healthcare Sales & Marketing Network) -- CSA Medical, Inc., today announced that over hal... Devices CSA Medical, cryotherapy, RejuvenAir, COPD, Bronchitis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 11, 2020 Category: Pharmaceuticals Source Type: news
CSA Medical Announces First Procedure in the SPRAY-CB Pivotal Trial for the Treatment of Chronic Bronchitis
The SPRAY-CB trial marks the first pivotal study of a medical device therapy targeting the underlying cause of Chronic Bronchitis BOSTON, Oct. 22, 2020 -- (Healthcare Sales & Marketing Network) -- CSA Medical Inc., a developer of medical devices advanc... Devices CSA Medical, cryotherapy, RejuvenAir System, COPD (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 22, 2020 Category: Pharmaceuticals Source Type: news
MASCC/ISOO Update Guidelines for Management of Mucositis
Topics include basic oral care, photobiomodulation therapy, cryotherapy, natural interventions (Source: The Doctors Lounge - Psychiatry)
Source: The Doctors Lounge - Psychiatry - August 31, 2020 Category: Psychiatry Tags: Gastroenterology, Oncology, ENT, Psychiatry, Radiology, Anesthesiology & amp; Pain, Journal, Source Type: news
Channel Medsystems(R) Receives FDA Approval of its Latest Cerene(R) Cryotherapy Device for the Treatment of Heavy Menstrual Bleeding in the Office Setting
Next-generation technology enhances ease-of-use for physicians and streamlines manufacturability The Company is targeting limited market introduction in Q42020 and commercial launch of the Cerene® Device in the first half of 2021 EMERYVILLE, Cali... Devices, FDA Channel Medsystems, Cerene, Cryotherapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 21, 2020 Category: Pharmaceuticals Source Type: news
Cryoablation Study for Mesothelioma Opening at UCLA
Researchers at UCLA Jonsson Comprehensive Cancer Center will soon begin studying the pre-surgery use of cryoablation as a potential early adjuvant therapy for patients with pleural mesothelioma. The pilot study will measure immune system stimulation through local tumor infiltration in hopes of extending patient survival in the future. Cryoablation, also known as cryotherapy or cryosurgery, freezes localized tumors with liquid nitrogen or argon gas. It has been proven effective in killing tumor cells with extreme cold. It is currently used on kidney, liver and prostate cancers, but its use in priming a person’s own i...
Source: Asbestos and Mesothelioma News - July 1, 2020 Category: Environmental Health Authors: Fran Mannino Source Type: news
SPA DOCTOR: How a cryotherapy chamber can help you help you battle through a bad bout of jet-lag
SPA DOCTOR: In need of an energy boost, I turned to KXU, a West London fitness studio and spa favoured by both Prince Harry and Princess Beatrice. (Source: the Mail online | Health)
Source: the Mail online | Health - March 14, 2020 Category: Consumer Health News Source Type: news
Proposed Legislation Targets a Critical Regulatory-Reimbursement Gap for Medical Devices
Reggie DyeÂ went 15 years without seeing a physician, in part because he had always been incredibly healthy. He regularly does high-intensity worksouts, enjoys hiking, golf, and can't remember the last time he even had a cold. But a preventative health evaluation incentive program his company offered in 2016 taught him that even the healthiest individuals are not immune to prostate cancer. After twoÂ prostate-specific antigen (PSA) screening tests, followed by additional testing, Dye was diagnosed with localized prostate cancer. At first, heÂ was given the choice of active surveillance, als...
Source: MDDI - March 11, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
This Is Your Body On Cryotherapy
You might want to think twice before taking the (freezing cold) plunge. (Source: Healthy Living - The Huffington Post)
Source: Healthy Living - The Huffington Post - March 10, 2020 Category: Consumer Health News Source Type: news
How to Survive Medtech & #039;s & #039;Death Valley & #039;
Medical device companies attempting to market a new treatment in the U.S. often make the erroneous assumption that winning FDA approvalÂ is the final destination, and success is theirs. In fact, going through the regulatory process is only the halfway point. The grueling path from FDA approval to reimbursement is like a treacherous walk through Death Valley and many companies donât make it through. In this case study, I discussÂ the trials and triumphs of bringing robotic high intensity focused ultrasound (HIFU), a non-invasive procedure for localized prostate cancer, to the U.S.&Aci...
Source: MDDI - August 24, 2019 Category: Medical Devices Authors: Marc Oczachowski Tags: Regulatory and Compliance Business Source Type: news
Whole body cryotherapy is a growing trend at spas and wellness centers, thanks in part to its popularity among athletes and celebrities. But it can be risky, and experts question how well it works. (Source: WebMD Health)
Source: WebMD Health - August 13, 2019 Category: Consumer Health News Source Type: news
Cryotherapy Injury: What Happened To Antonio Brown's Feet
In his first season with the Oakland Raiders, the wide receiver seems to have suffered a cold injury. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - August 8, 2019 Category: Pharmaceuticals Authors: Bruce Y. Lee, Contributor Source Type: news
Florence and CryoTherapeutics secure funding, NHS Wales signs new deal with Microsoft, and more news briefs
Also: Belgian startup epihunter adds new functionality to app; Inhealthcare reveals three-year deal with NHS trust; mySugr receives award in Lausanne. (Source: mobihealthnews)
Source: mobihealthnews - June 28, 2019 Category: Information Technology Source Type: news
Whole-Body Cryotherapy a Hot New Treatment for Depression? Whole-Body Cryotherapy a Hot New Treatment for Depression?
The idea of eventually offering cryotherapy as an adjunct to standard depression treatment has been proposed by investigators after finding the procedure improves mood and depressive symptoms.Medscape Medical News (Source: Medscape Psychiatry Headlines)
Source: Medscape Psychiatry Headlines - April 11, 2019 Category: Psychiatry Tags: Psychiatry News Source Type: news
Cold air therapy clinic to open in East Sacramento
Temperatures sink as low as minus 166 degrees Fahrenheit within the full-immersion cryotherapy tank. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - February 12, 2019 Category: American Health Authors: Felicia Alvarez Source Type: news
Fitness Recovery Tech: What Is Cryotherapy, What Are The Benefits, And How Does It Work?
I gave cryotherapy a try to see if the latest innovation in fitness recovery actually works (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 29, 2019 Category: Pharmaceuticals Authors: Lee Bell, Contributor Source Type: news
What Complications Can Gastrostomy Tubes Have?
Discussion Gastrostomy tubes (GT or GTubes) have been used to support patients for about a century. They are placed between the abdominal skin and the stomach either percutaneously or surgically. The tubes can be a standard long tube with either a bumper or inflatable balloon internally and externally they have a retention piece to hold the GT in place. A button or low profile tube are similar but extend just beyond the skin. Reasons for GT placement include: Nutritional support Hydration maintenance Medication management Aspiration avoidance Gastric stasis decompression Obstruction bypass Quality of life improvement for...
Source: PediatricEducation.org - January 21, 2019 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news
Cryotherapy malfunction results in burn, blisters
(Reuters Health) - Whole-body cryotherapy - a trendy procedure that exposes the naked body to subzero temperatures - isn't backed by evidence and can be risky, doctors say. (Source: Reuters: Health)
Source: Reuters: Health - January 1, 2019 Category: Consumer Health News Tags: healthNews Source Type: news
What Causes Post-Inflammatory Hypopigmentation?
Discussion Hypopigmentation can be worrisome for many families because of cosmesis and the worry that “something is wrong.” The normal natural changes in skin-tone over the year due to different light exposure and wide variations within individuals is not something that many people are aware of. Post-inflammatory hypopigmentation is a common cause of hypopigmentation. Vitiligo is the most common cause of depigmentation. Vitiligo is an acquired, depigmenting disorder with typical lesions appearing as milky white macules with distinct margins that are not scaly. Hair (including eyebrows and eyelashes) can be dep...
Source: PediatricEducation.org - November 12, 2018 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news
Cryotherapy May Curb Taxane-Induced Dermatologic Side Effects Cryotherapy May Curb Taxane-Induced Dermatologic Side Effects
Cooling the scalp may help prevent taxane-induced alopecia, whereas frozen gloves and socks may prevent nail and cutaneous side effects of the drugs, researchers say.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 8, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news
Frostbite After Cryotherapy?
Discussion Veruccae plantaris or plantar warts are caused by Human Papillomavirus which causes benign epidermal tumors that often have a cauliflower pattern on the foot that may be elevated or flush with the surrounding skin. Lesions may resemble calluses but the normal footprint pattern is disrupted. The lesions often have pinpoint hemorrhages that appear as black dots. In an immunocompetent individual, the lesions usually have spontaneous resolution within 2 years but the infection may spread to create additional lesions. The lesions may also cause pain or discomfort because of their size or location. There are numerous...
Source: PediatricEducation.org - October 29, 2018 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news
Cryotherapy chain plans midtown, Elk Grove, Folsom locations (PHOTOS)
US Cryotherapy plans three new locations for its subzero-temperature treatments in the Sacramento area. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - October 22, 2018 Category: American Health Authors: Felicia Alvarez Source Type: news
Cryotherapy chain plans midtown, Elk Grove, Folsom locations (PHOTOS)
US Cryotherapy plans three new locations for its subzero-temperature treatments in the Sacramento area. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 22, 2018 Category: Biotechnology Authors: Felicia Alvarez Source Type: news
CSA Medical ices $23m funding round
CSA Medical said yesterday that it put a $23 million debt-and-equity round on ice for the cryospray technology it’s developing. Boston-based CSA said Horizon Technology Finance led the round with a $15 million loan facility; existing shareholders ponied up $8 million in equity financing, the company said. The round’s first tranche included a $6 million loan from Horizon and another $5 million in equity financing from backers including SV Health Investors, Ascension Ventures and Intersouth Partners, CSA said. Proceeds are earmarked for expanding the commercial footprint into gastrointestinal indic...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Wall Street Beat CSA Medical Inc. Source Type: news
CSA Medical Secures $23 Million to Advance its Cryospray(TM) Therapies for Esophageal Disease and COPD
Financing to Support Expansion of CSA's truFreeze® Spray Cryotherapy Business for Esophageal Disease and Launch of the Reo Radial Catheter in 2019 for Barrett's Esophagus Also Supports CE Mark and Pivotal Clinical Study Launch for RejuvenAir® Sp... Devices, Venture Capital CSA Medical, Cryospray, RejuvenAir, Esophageal Disease, COPD (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 8, 2018 Category: Pharmaceuticals Source Type: news
U of A professor's TV show debunking alternative therapies will be on Netflix
In Tim Caulfield’s show 'A User’s Guide to Cheating Death,' he tries cryotherapy, napper-cizing and other alternative therapies popularized by pop culture. (Source: CBC | Health)
Source: CBC | Health - August 1, 2018 Category: Consumer Health News Tags: News/Canada/Edmonton Source Type: news
Effects of Cryotherapy on Paclitaxel-Induced Neuropathy Effects of Cryotherapy on Paclitaxel-Induced Neuropathy
Wearing frozen flexible gloves and socks during infusion may reduce symptoms of paclitaxel-induced peripheral neuropathy.Journal of the National Cancer Institute (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 30, 2018 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news
Tanzania:Regions Supplied With Cervical Cancer Screening Machines
[Daily News] Mwanza -THE Ariel Glasser Pediatric Aids Healthcare Initiative (AGPAHI) has handed over 17 Cryotherapy machines worth 115.6m/- to Mwanza, Geita, Mara, Simiyu, Shinyanga and Tanga regions to facilitate in screening women with cervical cancer symptoms. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - March 29, 2018 Category: African Health Source Type: news
Kangaroo to Get Cryotherapy Treatment for Arthritis
(NEW YORK) — An aging kangaroo who calls the Bronx Zoo home is receiving cryotherapy treatment for arthritis. The treatment is a high-tech alternative to ice baths that humans have used for years. Zoo director Jim Breheny tells the Daily News that the nearly 15-year-old marsupial named Dave is getting up there and his stiff joints are aching. Breheny says the treatment might sound exotic but that it’s really just one course of healing the 200 medical experts at the zoo in New York City utilize to treat some 7,000 different species. Dave’s saga with localized cryotherapy treatment will be documented by Ani...
Source: TIME: Science - March 10, 2018 Category: Science Authors: Associated Press Tags: Uncategorized animals APH healthytime onetime Source Type: news
Only U.S. Cryotherapy Trial for Mesothelioma Finds Success
Thoracic surgeon Dr. Shanda Blackmon at the Mayo Clinic in Rochester, Minnesota, believes there is a place for cryotherapy in the future multidisciplinary treatment of pleural mesothelioma. She wants to show it with this groundbreaking clinical trial. “We think [cryotherapy] could play an important role in treatment,” Blackmon told Asbestos.com. “So far, things look promising, but you can’t say anything specific without more numbers. Right now, it’s a little like telling a story.” Cryotherapy involves destroying cancer cells, or any abnormal tissues, by freezing them with controlled nitr...
Source: Asbestos and Mesothelioma News - February 14, 2018 Category: Environmental Health Authors: Daniel King Tags: ADI-PEG 20 cryoablation cryotherapy intrapleural measles virus Mayo Clinic mesothelioma clinical trial Opdivo pacific mesothelioma center pleural mesothelioma pleuroscopy Shanda Blackmon Surgery for Mesothelioma After Radiation Thera Source Type: news
New Study Finds truFreeze(R) Spray Cryotherapy Less Painful than Radiofrequency Ablation for Treatment of Barrett's Esophagus Related Diseases
LEXINGTON, Mass., Feb. 6, 2018 -- (Healthcare Sales & Marketing Network) -- CSA Medical is pleased to announce that in a multi-center prospective study conducted at three leading academic centers published in the Journal of Clinical Gastroenterology (Liqu... Devices, Gastroenterology CSA Medical, truFreeze, Barrett's Esophagus, cryotherapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 6, 2018 Category: Pharmaceuticals Source Type: news
Foreo's 'UFO' can give you a spa-level face mask in 90 sec
Foreo's bizarre booth at CES promotes a $300 product dubbed the UFO, which combines the techniques of thermo-therapy, cryotherapy, and light stimulation for a spa-level face treatment. (Source: the Mail online | Health)
Source: the Mail online | Health - January 11, 2018 Category: Consumer Health News Source Type: news
7 medtech stories we missed this week: Dec. 8, 2017
[Image from unsplash.com]From Minimus Spine’s European distribution deal to Stimwave receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Minimus Spine inks EU distribution deal Minimus Spine announced in a Dec. 4 press release that it has signed its first European distribution deal with Italian company Moss and has completed its first commercial order. Moss has exclusive distribution rights to distribute in Italy, Germany, Switzerland and the U.K. 2. Elanix, Dermacon sign wound management development deal Elanix Biotechnologies and Dermacon...
Source: Mass Device - December 8, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiac Assist Devices Cardiovascular Diagnostics Food & Drug Administration (FDA) Hospital Care Pain Management Regulatory/Compliance Cagent Vascular CSA Medical Inc. Dermacon Elanix Life Spine Inc. MedTech Minimus Spin Source Type: news
Medical News Today: I experienced -80 & deg;C and lived to tell the tale
Whole-body cryotherapy involves standing in a small chamber set to -80 °C. I tried it out so that you don't have to, and this is what it felt like. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - December 6, 2017 Category: Consumer Health News Tags: Complementary Medicine / Alternative Medicine Source Type: news
Video: Cryotherapy of the esophagus
Cryotherapy of the esophagus uses liquid nitrogen to freeze and destroy abnormal cells in your esophagus. Cryotherapy may be used to treat Barrett's esophagus. (Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - November 29, 2017 Category: Consumer Health News Source Type: news
Intense Cold Therapy Salons Opening In Boston Area
BOSTON (CBS) – We all know that ice is good for an injury to reduce swelling, but would cooling your whole body work to reduce all of your aches and pains? Those who believe in cryotherapy say yes and the treatment is becoming more available in the Boston area. Kelly Strickland just opened a new facility in West Roxbury. “Essentially what cryotherapy is, is the extreme use of cold therapy in a confined area to create a reaction in your body to help with pain and inflammation and muscle soreness,” she said. Inside her salon is a room with a vertical chamber called a cryosauna. It uses liquid nitrogen to c...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - October 21, 2017 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health Local News Syndicated Local cryotherapy Dr. Mallika Marshall Source Type: news
Cryotherapy May Prevent Chemo - Induced Neuropathy
Breast cancer patients on paclitaxel had lower incidence of peripheral neuropathy with cryotherapy (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - October 20, 2017 Category: Cancer & Oncology Tags: Gynecology, Nursing, Oncology, Journal, Source Type: news
Medical News Today: What are the benefits of cryotherapy?
We look at the benefits of cryotherapy including weight loss, inflammation reduction, and the possibility of it preventing dementia. Learn more here. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - October 19, 2017 Category: Consumer Health News Tags: Complementary Medicine / Alternative Medicine Source Type: news
Cryotherapy May Help Prevent Neuropathy in Cancer Patients (CME/CE)
(MedPage Today) -- Less CIPN in patients wearing ice-cold gloves and socks after taxane therapy (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - October 12, 2017 Category: Primary Care Source Type: news
Frozen Gloves, Socks Reduce CIPN in Patients With Breast Cancer Frozen Gloves, Socks Reduce CIPN in Patients With Breast Cancer
Cryotherapy delivered to the hands and feet during weekly paclitaxel chemotherapy significantly reduces the incidence of peripheral neuropathy in patients with breast cancer.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 12, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Study finds cold therapy may be effective at controlling cancer treatment side effects
(Oxford University Press USA) A new study published in the Journal of the National Cancer Institute finds that cryotherapy, specifically having chemotherapy patients wear frozen gloves and socks for 90-minute periods, is useful for preventing symptoms of neuropathy. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 12, 2017 Category: International Medicine & Public Health Source Type: news
Living With Cancer: Minimally invasive treatment for prostate cancer
Cryotherapy for prostate cancer? This minimally invasive procedure can be an alternative to removing the prostate gland surgically. Learn more about cryotherapy for prostate cancer ? why it's done, what to expect, possible risks and whether it might be right for you. Symptoms of prostate cancer? Prostate cancer may cause no signs or symptoms in [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - September 22, 2017 Category: Databases & Libraries Source Type: news
CSA Medical wins another FDA expansion for TruFreeze cryotherapy
Endoscopic cryo-ablation company CSA Medical said today it won expanded FDA 510(k) clearance for its TruFreeze spray cryotherapy system, now cleared for use on patients with Barrett’s esophagus with low grade dysplasia. With the clearance, the device is now approved for both low and high grade dysplasia as well as malignancies, the Boston-based company said. “Over the past few years, studies have underscored the potential risk for Barrett’s esophagus with low grade dysplasia to progress to esophageal adenocarcinoma. Intervening at this level of dysplasia has become common practice and is recogni...
Source: Mass Device - August 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Regulatory/Compliance CSA Medical Inc. Source Type: news
CSA Medical Announces Expansion of truFreeze(R) Label to Include Barrett's Esophagus with Low Grade Dysplasia
From Barrett's Esophagus to Malignancy - Only truFreeze® BOSTON, Aug. 31, 2017 -- (Healthcare Sales & Marketing Network) -- CSA Medical announced on Thursday, the expansion of its truFreeze® label with the addition of Barrett's Esophagus with l... Devices, Interventional, FDA CSA Medical, truFreeze, Barrett's Esophagus, cryotherapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 31, 2017 Category: Pharmaceuticals Source Type: news
Channel Medsystems(R) Secures $14.1mm Financing for Office-Based Treatment of Heavy Menstrual Bleeding
EMERYVILLE, Calif., Aug. 23, 2017 -- (Healthcare Sales & Marketing Network) -- Channel Medsystems, developer of an innovative, physician office-based therapy for heavy menstrual bleeding, announced today that it has secured a $14.1mm Series C-1 financing.... Devices, Venture Capital Channel Medsystems, Cerene Cryotherapy, endometrial cryoablation (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 23, 2017 Category: Pharmaceuticals Source Type: news
Meditation in fashion? Designers share how the practice helps them reboot, refresh and stay grounded
Meditation: it never goes out of style. While fashion folk constantly seek out the latest wellness trend — IV drips, sensory deprivation, infrared saunas, cryotherapy, turmeric and beet lattes — the centuries-old practice is finding new currency.“It’s tough within the industry now,” says Khajak... (Source: L.A. Times - Health)
Source: L.A. Times - Health - August 11, 2017 Category: Consumer Health News Authors: Kristen Tauer | WWD Source Type: news
Cryotherapy or cervical cancer screening in HIV-infected women?
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - August 1, 2017 Category: Drugs & Pharmacology Source Type: news
CSA Medical wins expanded FDA nod for TruFreeze system
Endoscopic cryo-ablation company CSA Medical said today it won FDA 510(k) clearance for a 3rd spray kit, the rapid AV spray kit, for its TruFreeze system. The Boston-based company’s TruFreeze system is designed as a cryosurgical tool designed for use in dermatology, gynecology, general surgery and to ablate benign and malignant lesions. The newly cleared addition is designed to shorten the time to liquid nitrogen spray by 50%, the company said. The company touted the TruFreeze device as the only ablation technology designed to ablate Barrett’s Esophagus with a high grade dysplasia or cancers as such a...
Source: Mass Device - July 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance CSA Medical Inc. Source Type: news
Channel Medsystems wins CE Mark for Cerene cryotherapy device
Channel Medsystems said today it won CE Mark approval in the European Union for its Cerene cryotherapy endometrial ablation device designed for treating women with heavy menstrual bleeding due to benign causes. The Emeryville, Calif.-based company said that current endometrial ablation procedures can be painful and require general anesthesia, but its Cerene device and associated procedure are comfortable and usable in an office setting with no post-procedure downtime. “Finding the right treatment can be a challenge for women. The introduction of the Cerene procedure in Europe will allow gynecologists t...
Source: Mass Device - June 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Women's Health Channel Medsystems Source Type: news
Channel Medsystems(R) Earns CE Mark Approval for the Cerene(R) Cryotherapy Device
EMERYVILLE, Calif., June 26, 2017 -- (Healthcare Sales & Marketing Network) -- Channel Medsystems, the developer of an innovative, physician office-based therapy for heavy menstrual bleeding, announced today that it has earned CE Mark approval, allowing t... Devices, Regulatory Channel Medsystems, Cerene Cryotherapy, endometrial cryoablation (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 26, 2017 Category: Pharmaceuticals Source Type: news